LABELS · e230c170-2a16-47d0-bce7-ac0414c192f7

LEVOXYL

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2020-12-15
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including LEVOXYL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , Overdosage (10) ] . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. Thyroid hormones, including LEVOXYL, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity ( 6 , 7.7 , 10 ).

Indications and usage: exact source text

1 INDICATIONS AND USAGE LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. ( 1 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . Limitations of Use : LEVOXYL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Full extracted label fields

application numbers

NDA021301

boxed warning exact

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including LEVOXYL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , Overdosage (10) ] . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. Thyroid hormones, including LEVOXYL, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity ( 6 , 7.7 , 10 ).

brand names

LEVOXYL

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=758588c3-c63e-491b-0aa2-4f50d80cb174

generic names

LEVOTHYROXINE SODIUM

e230c170-2a16-47d0-bce7-ac0414c192f7

indications and usage exact

1 INDICATIONS AND USAGE LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. ( 1 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . Limitations of Use : LEVOXYL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

indications and usage tables exact

is original packager

true

manufacturer names

Pfizer Laboratories Div Pfizer Inc

matched search terms

cancer

package ndcs

60793-850-10
60793-850-01
60793-851-10
60793-851-01
60793-852-10
60793-852-01
60793-853-10
60793-853-01
60793-854-10
60793-854-01
60793-855-10
60793-855-01

product ndcs

60793-850
60793-851
60793-852
60793-853
60793-854
60793-855
60793-856
60793-857
60793-858
60793-859
60793-860

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

892246
892251
966157
966164
966170
966175
966184
966190
966194
966200
966204
966211

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 700
total: 830

terms

https://open.fda.gov/terms/

sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl effective time

20201215

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

substance names

LEVOTHYROXINE SODIUM

uniis

9J765S329G

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA021301
payload
all indexed label documents
Appl No
021301
Application Docs Date
2008-07-09 00:00:00
Application Docs ID
15134
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021301s026lbl.pdf
Submission No
26
Submission Type
SUPPL
Appl No
021301
Application Docs Date
2011-03-21 00:00:00
Application Docs ID
15135
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf
Submission No
27
Submission Type
SUPPL
Appl No
021301
Application Docs Date
2001-05-25 00:00:00
Application Docs ID
36609
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21301lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021301
Application Docs Date
2005-03-10 00:00:00
Application Docs ID
36610
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21301s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
021301
Application Docs Date
2018-12-21 00:00:00
Application Docs ID
56986
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021301s038lbl.pdf
Submission No
38
Submission Type
SUPPL
all submission records
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2001-05-25 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
2002-04-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2002-07-17 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
3
Submission Status
AP
Submission Status Date
2002-12-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
6
Submission Status
AP
Submission Status Date
2003-07-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2005-03-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
26
Submission Status
AP
Submission Status Date
2008-07-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
N/A
Submission Class Code ID
4
Submission No
27
Submission Status
AP
Submission Status Date
2011-03-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
6
Submission No
28
Submission Status
AP
Submission Status Date
2009-09-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
34
Submission Status
AP
Submission Status Date
2012-12-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
35
Submission Status
AP
Submission Status Date
2014-05-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021301
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
37
Submission Status
AP
Submission Status Date
2014-11-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021301
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021301
has approved submission record
true
latest approved submission date
2018-12-20
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
021301
Application Docs Date
2018-12-21 00:00:00
Application Docs ID
56986
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021301s038lbl.pdf
Submission No
38
Submission Type
SUPPL
official application record
Appl No
021301
Appl Public Notes
Appl Type
NDA
Sponsor Name
KING PHARMS
openfda application present
true
products
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
004
Reference Drug
1
Reference Standard
0
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
005
Reference Drug
1
Reference Standard
0
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
006
Reference Drug
1
Reference Standard
0
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
007
Reference Drug
1
Reference Standard
0
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
008
Reference Drug
1
Reference Standard
0
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
009
Reference Drug
1
Reference Standard
0
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
010
Reference Drug
1
Reference Standard
0
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
011
Reference Drug
1
Reference Standard
1
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021301
Drug Name
LEVOXYL
Form
TABLET;ORAL
Product No
012
Reference Drug
1
Reference Standard
0
Strength
0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
marketing status
Discontinued

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 443
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. ( 1 ) Limitations
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 0

current approval status

not_reconciled

duplicate text group

dup-4c8a1fb94d7c5f42fb1f

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-1806fb2c7b5671f1e77a

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

end: 61
end exclusive: true
exact text: is L-thyroxine (T4) indicated
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 32

qualifier mentions

context exact
ICATIONS AND USAGE LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in p
kind
age
polarity
not_inferred
span
end
74
end exclusive
true
exact text
pediatric
label id
e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start
65
context exact
SAGE LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal),
kind
age
polarity
not_inferred
span
end
93
end exclusive
true
exact text
adult patients
label id
e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start
79

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 243
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 2 · unclassified context

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 625
end exclusive: true
exact text: ne (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. ( 1 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism d
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 44

current approval status

not_reconciled

duplicate text group

dup-a27c2737638626917219

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-257d8ef59297c911eee8

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 425
end exclusive: true
exact text: ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 244

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · limitation of use

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 769
end exclusive: true
exact text: d hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. ( 1 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement the
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 226

current approval status

not_reconciled

duplicate text group

dup-194f0c0cb3443c95e4b7

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-5881419dcaf5d65330bf

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 569
end exclusive: true
exact text: ( 1 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 426

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 4 · limitation of use

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 874
end exclusive: true
exact text: n the management of well-differentiated thyroid cancer. ( 1 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hy
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 370

current approval status

not_reconciled

duplicate text group

dup-1529e86f3e67582f8af7

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-f6b2bef2e2937a368c49

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 674
end exclusive: true
exact text: ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 570

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 5 · positive indication candidate

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1087
end exclusive: true
exact text: ppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-di
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 475

current approval status

not_reconciled

duplicate text group

dup-115666d3391465cb12b6

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-94ae25f93ce5651ecab1

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

end: 716
end exclusive: true
exact text: is indicated
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 704

qualifier mentions

context exact
( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thy
kind
age
polarity
not_inferred
span
end
729
end exclusive
true
exact text
pediatric
label id
e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start
720
context exact
( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary
kind
age
polarity
not_inferred
span
end
748
end exclusive
true
exact text
adult patients
label id
e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start
734

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 887
end exclusive: true
exact text: ( 1 ) Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 675

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 6 · positive indication candidate

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1316
end exclusive: true
exact text: roidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . Limitations of Use : LEVOXYL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment w
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 688

current approval status

not_reconciled

duplicate text group

dup-a88b9d3268dcb620ad82

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-f8ded190a190401c18a0

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

end: 977
end exclusive: true
exact text: is indicated
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 965

qualifier mentions

context exact
imulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine
kind
age
polarity
not_inferred
span
end
990
end exclusive
true
exact text
pediatric
label id
e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start
981
context exact
one, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the man
kind
age
polarity
not_inferred
span
end
1009
end exclusive
true
exact text
adult patients
label id
e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start
995

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 1116
end exclusive: true
exact text: Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer .
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 888

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 7 · limitation of use

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1502
end exclusive: true
exact text: d-Stimulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . Limitations of Use : LEVOXYL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 917

current approval status

not_reconciled

duplicate text group

dup-f003b5f44b40b8a103db

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-eef376ba0b451ec3310b

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 1394
end exclusive: true
exact text: Limitations of Use : LEVOXYL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] .
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 1117

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 8 · limitation of use

application numbers

NDA021301

brand names

LEVOXYL

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1502
end exclusive: true
exact text: d nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 1195

current approval status

not_reconciled

duplicate text group

dup-ee548823c926232ec0f9

extraction review status

automated_candidate_pending_source_review

generic names

LEVOTHYROXINE SODIUM

ind-span-dbed9cc29b5d25cb806e

label id

e230c170-2a16-47d0-bce7-ac0414c192f7

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 1502
end exclusive: true
exact text: LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
label id: e230c170-2a16-47d0-bce7-ac0414c192f7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2225b216c25434a50c6514c37736caa26d81298f3446f83a70b8c2a7307ab90d
start: 1395

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e230c170-2a16-47d0-bce7-ac0414c192f7%22

spl effective date

2020-12-15

spl set id

758588c3-c63e-491b-0aa2-4f50d80cb174

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice