LABELS · 35a7647b-9644-4c4c-8011-a0d5969c0a56

Unithroid

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: 2019-06-19
Captured: 2026-09-09T23:37:42.544548+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 UNITHROID, 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 UNITHROID, 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 UNITHROID 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 UNITHROID 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: UNITHROID 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 UNITHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.4 )] . UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. UNITHROID 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 )

Full extracted label fields

application numbers

NDA021210

boxed warning exact

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including UNITHROID, 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 UNITHROID, 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

Unithroid

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07562e72-7eaa-4ce6-94f0-e08814787e50

generic names

LEVOTHYROXINE SODIUM

35a7647b-9644-4c4c-8011-a0d5969c0a56

indications and usage exact

1 INDICATIONS AND USAGE Hypothyroidism UNITHROID 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 UNITHROID 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: UNITHROID 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 UNITHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.4 )] . UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. UNITHROID 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 )

indications and usage tables exact

is original packager

true

manufacturer names

Amneal Pharmaceuticals LLC

matched search terms

cancer

package ndcs

60846-801-01
60846-810-01
60846-811-01
60846-812-01
60846-802-01
60846-803-01
60846-804-01
60846-805-01
60846-806-01
60846-807-01
60846-808-01
60846-809-01

product ndcs

60846-801
60846-810
60846-811
60846-812
60846-802
60846-803
60846-804
60846-805
60846-806
60846-807
60846-808
60846-809

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

892246
892251
892255
966220
966221
966222
966224
966225
966228
966232
966233
966235

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.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: 100
total: 830

terms

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

sha256

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url

source url

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spl effective date

2019-06-19

spl effective time

20190619

spl set id

07562e72-7eaa-4ce6-94f0-e08814787e50

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
NDA021210
payload
all indexed label documents
Appl No
021210
Application Docs Date
2000-08-21 00:00:00
Application Docs ID
14639
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
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Submission No
1
Submission Type
ORIG
Appl No
021210
Application Docs Date
2008-02-14 00:00:00
Application Docs ID
36360
Application Docs Title
0
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2
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4
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021210
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2018-12-12 00:00:00
Application Docs ID
56720
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021210s018lbl.pdf
Submission No
8
Submission Type
SUPPL
all submission records
Appl No
021210
Review Priority
STANDARD
Submission Class Code ID
17
Submission No
1
Submission Status
AP
Submission Status Date
2000-08-21 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
021210
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
2000-12-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021210
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
2
Submission Status
AP
Submission Status Date
2004-06-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021210
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
3
Submission Status
AP
Submission Status Date
2004-12-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021210
Review Priority
N/A
Submission Class Code ID
4
Submission No
4
Submission Status
AP
Submission Status Date
2008-02-08 00:00:00
Submission Type
SUPPL
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Appl No
021210
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
6
Submission Status
AP
Submission Status Date
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Submission Type
SUPPL
Submissions Public Notes
Appl No
021210
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2018-12-10 00:00:00
Submission Type
SUPPL
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Appl No
021210
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
9
Submission Status
AP
Submission Status Date
2014-09-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021210
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 posted label documents
Appl No
021210
Application Docs Date
2018-12-12 00:00:00
Application Docs ID
56720
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021210s018lbl.pdf
Submission No
8
Submission Type
SUPPL
official application record
Appl No
021210
Appl Public Notes
Appl Type
NDA
Sponsor Name
STEVENS J
openfda application present
true
products
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021210
Drug Name
UNITHROID
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
021210
Drug Name
UNITHROID
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
021210
Drug Name
UNITHROID
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
021210
Drug Name
UNITHROID
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
021210
Drug Name
UNITHROID
Form
TABLET;ORAL
Product No
005
Reference Drug
1
Reference Standard
0
Strength
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marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021210
Drug Name
UNITHROID
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
021210
Drug Name
UNITHROID
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
021210
Drug Name
UNITHROID
Form
TABLET;ORAL
Product No
008
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
021210
Drug Name
UNITHROID
Form
TABLET;ORAL
Product No
009
Reference Drug
1
Reference Standard
0
Strength
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marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021210
Drug Name
UNITHROID
Form
TABLET;ORAL
Product No
010
Reference Drug
1
Reference Standard
0
Strength
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marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021210
Drug Name
UNITHROID
Form
TABLET;ORAL
Product No
011
Reference Drug
1
Reference Standard
1
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
marketing status
Prescription
Active Ingredient
LEVOTHYROXINE SODIUM
Appl No
021210
Drug Name
UNITHROID
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

NDA021210

brand names

Unithroid

classification reasons

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ICATIONS AND USAGE Hypothyroidism UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thy
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biomarker and test: Source null
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prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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exact text: idism UNITHROID 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 UNITHROID 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: UNITHROID 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
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exact text: Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression UNITHROID 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.
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spl effective date

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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

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Passage 3 · limitation of use

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exact text: TSH) Suppression UNITHROID 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: UNITHROID 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 UNITHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.4 )] . UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. UNITHROID is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidi
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Preserved source evidence · Not medical advice