LABELS · cbb13358-54ac-4b7e-81dd-f188bc96174a

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: 2026-05-21
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 ( ) , 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 ( , 10 ).

Indications and usage: exact source text

1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, 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 in adult and pediatric patients, including neonates, 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 ( 5.1 )] . • Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. () • 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. () 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

NDA021116

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 ( ) , 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 ( , 10 ).

brand names

levothyroxine sodium

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3519c765-2077-4f23-8644-a6242ddbf743

generic names

LEVOTHYROXINE SODIUM

cbb13358-54ac-4b7e-81dd-f188bc96174a

indications and usage exact

1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, 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 in adult and pediatric patients, including neonates, 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 ( 5.1 )] . • Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. () • 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. () 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

Preferred Pharmaceuticals, Inc.

matched search terms

cancer

package ndcs

68788-7764-3
68788-7764-9

product ndcs

68788-7764

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage () 11/2023 Dosage and Administration ( 2.2 , 2.3 ) 11/2023 Warnings and Precautions ( 5.1 , 5.4 ) 11/2023

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

966249

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

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spl effective date

2026-05-21

spl effective time

20260521

spl set id

3519c765-2077-4f23-8644-a6242ddbf743

spl version

substance names

LEVOTHYROXINE SODIUM

uniis

9J765S329G

verification flags

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spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
not_identified_as_original_packager

Drugs@FDA application source records

application number
NDA021116
payload
all indexed label documents
Appl No
021116
Application Docs Date
2002-10-24 00:00:00
Application Docs ID
36151
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21116lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021116
Application Docs Date
2006-03-14 00:00:00
Application Docs ID
36152
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021116s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
021116
Application Docs Date
2017-09-01 00:00:00
Application Docs ID
49659
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021116s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
021116
Application Docs Date
2019-04-25 00:00:00
Application Docs ID
58413
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021116s017lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
021116
Application Docs Date
2023-11-17 00:00:00
Application Docs ID
76605
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021116s027lbl.pdf
Submission No
27
Submission Type
SUPPL
all submission records
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021116
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
27
Submission Status
AP
Submission Status Date
2023-11-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
23
Submission Status
AP
Submission Status Date
2022-04-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
21
Submission Status
AP
Submission Status Date
2021-12-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
17
Submission Status
AP
Submission Status Date
2019-04-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
16
Submission Status
AP
Submission Status Date
2016-05-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
2015-11-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2017-08-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
12
Submission Status
AP
Submission Status Date
2015-01-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2006-03-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
4
Submission Status
AP
Submission Status Date
2004-12-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021116
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2002-10-24 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA021116
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=021116
has approved submission record
true
latest approved submission date
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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
021116
Application Docs Date
2023-11-17 00:00:00
Application Docs ID
76605
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021116s027lbl.pdf
Submission No
27
Submission Type
SUPPL
official application record
Appl No
021116
Appl Public Notes
Appl Type
NDA
Sponsor Name
ALVOGEN
openfda application present
true
products
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021116
Drug Name
THYRO-TABS
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
021116
Drug Name
THYRO-TABS
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
021116
Drug Name
THYRO-TABS
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
004
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
005
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
006
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
007
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
008
Reference Drug
1
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
009
Reference Drug
1
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
010
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
011
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
021116
Drug Name
THYRO-TABS
Form
TABLET;ORAL
Product No
012
Reference Drug
1
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

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brand names

levothyroxine sodium

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structured indication

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exact text: dicated in adult and pediatric patients, including neonates, 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 in adult and pediatric patients, including neonates, 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 benefi
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exact text: Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, 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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prior therapy: Source null
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tumor histology: Source null

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Passage 3 · limitation of use

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levothyroxine sodium

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Preserved source evidence · Not medical advice