LABELS · 47e50f93-a701-747e-e063-6294a90a5259

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: 2026-01-08
Captured: 2026-09-09T23:37:44.904352+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=a8db0f7d-8863-9309-e053-2995a90a284a

generic names

LEVOTHYROXINE SODIUM

47e50f93-a701-747e-e063-6294a90a5259

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

true

manufacturer names

Lannett Company, Inc

matched search terms

cancer

package ndcs

0527-3281-46
0527-3281-43
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product ndcs

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HUMAN PRESCRIPTION DRUG

recent major changes exact

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ORAL

rxcuis

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source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.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

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total: 830

terms

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

sha256

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url

source url

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spl effective date

2026-01-08

spl effective time

20260108

spl set id

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spl version

substance names

LEVOTHYROXINE SODIUM

uniis

9J765S329G

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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
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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
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2
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SUPPL
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021342
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2008-06-12 00:00:00
Application Docs ID
36694
Application Docs Title
0
Application Docs Type ID
2
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021342s008s014lbl.pdf
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14
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SUPPL
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021342
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2017-12-07 00:00:00
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50625
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0
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23
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021342
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2026-05-21 00:00:00
Application Docs ID
85838
Application Docs Title
0
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2
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Submission No
28
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all submission records
Appl No
021342
Review Priority
STANDARD
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3
Submission No
28
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AP
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2026-05-04 00:00:00
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SUPPL
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Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
25
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AP
Submission Status Date
2017-01-12 00:00:00
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021342
Review Priority
STANDARD
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4
Submission No
24
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AP
Submission Status Date
2015-02-09 00:00:00
Submission Type
SUPPL
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Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
23
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AP
Submission Status Date
2017-12-05 00:00:00
Submission Type
SUPPL
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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
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AP
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2011-03-09 00:00:00
Submission Type
SUPPL
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Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
16
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AP
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Submission Type
SUPPL
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Appl No
021342
Review Priority
STANDARD
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3
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14
Submission Status
AP
Submission Status Date
2008-06-10 00:00:00
Submission Type
SUPPL
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Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
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AP
Submission Status Date
2008-06-10 00:00:00
Submission Type
SUPPL
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Appl No
021342
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
4
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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
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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
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latest approved submission date
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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
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0
Strength
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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
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Product No
009
Reference Drug
0
Reference Standard
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Strength
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marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021342
Drug Name
LEVO-T
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Product No
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0
Strength
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marketing status
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Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021342
Drug Name
LEVO-T
Form
TABLET;ORAL
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Strength
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marketing status
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Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021342
Drug Name
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Form
TABLET;ORAL
Product No
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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

NDA021342

brand names

Levothyroxine Sodium

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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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structured indication

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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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structured indication

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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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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