LABELS · d010d2e7-ebbe-496a-a65c-5c7c95ceb9ca

Levothyroxine Sodium

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: 2025-08-01
Captured: 2026-09-09T23:37:58.719708+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 levothyroxine sodium tablets, 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 levothyroxine sodium tablets 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 Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: • Levothyroxine sodium tablets are 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 levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. • Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets is L-thyroxine (T4) indicated for: • Hypothyroidism: As replacement therapy 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. - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Full extracted label fields

application numbers

NDA021342

boxed warning exact

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including levothyroxine sodium tablets, 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 levothyroxine sodium tablets 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

Levothyroxine Sodium

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e588c43-b9b5-478e-99f7-e197add3cd26

generic names

LEVOTHYROXINE SODIUM

d010d2e7-ebbe-496a-a65c-5c7c95ceb9ca

indications and usage exact

1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: • Levothyroxine sodium tablets are 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 levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. • Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets is L-thyroxine (T4) indicated for: • Hypothyroidism: As replacement therapy 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. - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

indications and usage tables exact

is original packager

manufacturer names

Proficient Rx LP

matched search terms

cancer

package ndcs

82804-222-30
82804-222-90

product ndcs

82804-222

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

892246

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.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: 600
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%22d010d2e7-ebbe-496a-a65c-5c7c95ceb9ca%22

spl effective date

2025-08-01

spl effective time

20250801

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
not_identified_as_original_packager
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA021342
payload
all indexed label documents
Appl No
021342
Application Docs Date
2002-03-01 00:00:00
Application Docs ID
15220
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21342lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021342
Application Docs Date
2008-06-12 00:00:00
Application Docs ID
15221
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021342s008s014lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
021342
Application Docs Date
2009-06-22 00:00:00
Application Docs ID
15222
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021342s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
021342
Application Docs Date
2003-12-11 00:00:00
Application Docs ID
36692
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21342scs001_Levo-T_lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
021342
Application Docs Date
2003-08-28 00:00:00
Application Docs ID
36693
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21342scs002_levoT_lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
021342
Application Docs Date
2008-06-12 00:00:00
Application Docs ID
36694
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021342s008s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
021342
Application Docs Date
2017-12-07 00:00:00
Application Docs ID
50625
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021342s023lbl.pdf
Submission No
23
Submission Type
SUPPL
Appl No
021342
Application Docs Date
2026-05-21 00:00:00
Application Docs ID
85838
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021342s028lbl.pdf
Submission No
28
Submission Type
SUPPL
all submission records
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
28
Submission Status
AP
Submission Status Date
2026-05-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
25
Submission Status
AP
Submission Status Date
2017-01-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
24
Submission Status
AP
Submission Status Date
2015-02-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
23
Submission Status
AP
Submission Status Date
2017-12-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
22
Submission Status
AP
Submission Status Date
2012-11-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
20
Submission Status
AP
Submission Status Date
2011-03-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
16
Submission Status
AP
Submission Status Date
2009-06-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2008-06-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2008-06-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
4
Submission Status
AP
Submission Status Date
2004-06-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
3
Submission Status
AP
Submission Status Date
2004-06-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
2
Submission Status
AP
Submission Status Date
2003-08-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021342
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=021342
has approved submission record
true
latest approved submission date
2026-05-04
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
021342
Application Docs Date
2026-05-21 00:00:00
Application Docs ID
85838
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021342s028lbl.pdf
Submission No
28
Submission Type
SUPPL
official application record
Appl No
021342
Appl Public Notes
Appl Type
NDA
Sponsor Name
CEDIPROF INC
openfda application present
true
products
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
001
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
002
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
003
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
004
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
005
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
006
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
007
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
008
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
009
Reference Drug
0
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
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
010
Reference Drug
0
Reference Standard
0
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
011
Reference Drug
0
Reference Standard
0
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
Product No
012
Reference Drug
0
Reference Standard
0
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription

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

NDA021342

brand names

Levothyroxine Sodium

classification reasons

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clinical review status

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exact text: 1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-depen
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exact text: 1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism.
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exact text: AGE Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: • Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benef
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exact text: Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated 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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approval pathway: Source null
biomarker and test: Source null
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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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exact text: ng Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: • Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatmen
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Preserved source evidence · Not medical advice