LABELS · 8b98dc0b-b9fa-42eb-81a0-07b4679d9332

EUTHYROX

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: 2026-01-27
Captured: 2026-09-09T23:37:54.830918+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 EUTHYROX, 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) , and Overdosage (10) ] . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. Thyroid hormones, including EUTHYROX, 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 , 10 ).

Indications and usage: exact source text

1 INDICATIONS AND USAGE EUTHYROX 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 thyrotropin-dependent 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 EUTHYROX 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 EUTHYROX is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer . Limitations of Use: EUTHYROX 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 EUTHYROX may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. EUTHYROX is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Full extracted label fields

application numbers

NDA021292

boxed warning exact

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including EUTHYROX, 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) , and Overdosage (10) ] . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. Thyroid hormones, including EUTHYROX, 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 , 10 ).

brand names

EUTHYROX

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275

generic names

LEVOTHYROXINE SODIUM

8b98dc0b-b9fa-42eb-81a0-07b4679d9332

indications and usage exact

1 INDICATIONS AND USAGE EUTHYROX 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 thyrotropin-dependent 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 EUTHYROX 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 EUTHYROX is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer . Limitations of Use: EUTHYROX 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 EUTHYROX may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. EUTHYROX 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

Provell Pharmaceuticals, LLC

matched search terms

cancer

package ndcs

72305-025-30
72305-025-90
72305-050-30
72305-050-90
72305-075-30
72305-075-90
72305-088-30
72305-088-90
72305-100-30
72305-100-90
72305-112-30
72305-112-90

product ndcs

72305-050
72305-025
72305-075
72305-088
72305-100
72305-112
72305-125
72305-137
72305-150
72305-175
72305-200

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

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892251
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966166
966173
966177
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source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.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: 500
total: 830

terms

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

sha256

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url

source url

https://api.fda.gov/drug/label.json?search=id%3A%228b98dc0b-b9fa-42eb-81a0-07b4679d9332%22

spl effective date

2026-01-27

spl effective time

20260127

spl set id

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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
NDA021292
payload
all indexed label documents
Appl No
021292
Application Docs Date
2002-05-31 00:00:00
Application Docs ID
15125
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021292
Application Docs Date
2009-04-03 00:00:00
Application Docs ID
36600
Application Docs Title
0
Application Docs Type ID
2
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Submission No
2
Submission Type
SUPPL
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021292
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2018-09-18 00:00:00
Application Docs ID
55496
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
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021292
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2018-09-18 00:00:00
Application Docs ID
55497
Application Docs Title
0
Application Docs Type ID
2
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
Submission No
5
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SUPPL
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021292
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Application Docs ID
55498
Application Docs Title
0
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2
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
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6
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SUPPL
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021292
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2022-05-03 00:00:00
Application Docs ID
70915
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0
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2
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all submission records
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AP
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Submission Type
ORIG
Submissions Public Notes
Appl No
021292
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2009-03-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021292
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
4
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AP
Submission Status Date
2018-09-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021292
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2018-09-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021292
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
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Submission Status
AP
Submission Status Date
2018-09-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021292
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2022-04-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021292
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
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has approved submission record
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latest approved submission date
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latest label selection rule
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latest posted label documents
Appl No
021292
Application Docs Date
2022-05-03 00:00:00
Application Docs ID
70915
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf
Submission No
10
Submission Type
SUPPL
official application record
Appl No
021292
Appl Public Notes
Appl Type
NDA
Sponsor Name
EMD SERONO INC
openfda application present
true
products
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
001
Reference Drug
0
Reference Standard
0
Strength
0.025MG
marketing status
Discontinued
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
002
Reference Drug
0
Reference Standard
0
Strength
0.05MG
marketing status
Discontinued
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
003
Reference Drug
0
Reference Standard
0
Strength
0.075MG
marketing status
Discontinued
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
004
Reference Drug
0
Reference Standard
0
Strength
0.088MG
marketing status
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Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
005
Reference Drug
0
Reference Standard
0
Strength
0.1MG
marketing status
Discontinued
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
006
Reference Drug
0
Reference Standard
0
Strength
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marketing status
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Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
007
Reference Drug
0
Reference Standard
0
Strength
0.125MG
marketing status
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Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
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Product No
008
Reference Drug
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Strength
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marketing status
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Active Ingredient
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Appl No
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Form
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Product No
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0
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marketing status
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LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
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TABLET;ORAL
Product No
010
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0
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0
Strength
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marketing status
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Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
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Product No
011
Reference Drug
0
Reference Standard
0
Strength
0.2MG
marketing status
Discontinued
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021292
Drug Name
EUTHYROX
Form
TABLET;ORAL
Product No
012
Reference Drug
0
Reference Standard
0
Strength
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marketing status
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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

NDA021292

brand names

EUTHYROX

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

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context span

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exact text: 1 INDICATIONS AND USAGE EUTHYROX 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 thyrotropin-dependent well-differentiated thyroid can
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LEVOTHYROXINE SODIUM

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qualifier mentions

context exact
CATIONS AND USAGE EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in p
kind
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AGE EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal),
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regulatory links

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exact text: 1 INDICATIONS AND USAGE EUTHYROX 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.
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source url

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spl effective date

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structured indication

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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

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brand names

EUTHYROX

classification reasons

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clinical review status

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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 thyrotropin-dependent 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 du
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exact text: ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
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source url

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structured indication

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limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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Passage 3 · limitation of use

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exact text: ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent 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 EUTHYROX is indicated in pediatric and adult patients as a replacement th
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exact text: ( 1 ) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
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source url

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spl effective date

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structured indication

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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

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Passage 4 · limitation of use

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Preserved source evidence · Not medical advice