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LABELS · 1b592020-c769-2381-e063-6394a90a74b7

levothyroxine sodium

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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
2024-06-20
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. 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. 1 INDICATIONS AND USAGE Levothyroxine Sodium Tablets are 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. 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.
Full extracted label fields
application numbers
  1. NDA021116
boxed warning exact
  1. 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
  1. levothyroxine sodium
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a215da96-acd9-6b8d-e053-2995a90a7e0d
generic names
  1. LEVOTHYROXINE SODIUM
id
1b592020-c769-2381-e063-6394a90a74b7
indications and usage exact
  1. 1 INDICATIONS AND USAGE Levothyroxine Sodium Tablets are 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. 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.
indications and usage tables exact
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        substance names
        1. LEVOTHYROXINE SODIUM
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        1. application number
          NDA021116
          payload
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          1. Appl No
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          5. Appl No
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          1. Appl No
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            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
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            2023-11-16 00:00:00
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          2. Appl No
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            STANDARD
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          3. Appl No
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          4. Appl No
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            STANDARD
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            2019-04-23 00:00:00
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          5. Appl No
            021116
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            STANDARD
            Submission Class Code ID
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          6. Appl No
            021116
            Review Priority
            STANDARD
            Submission Class Code ID
            4
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            2015-11-09 00:00:00
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          7. Appl No
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            Review Priority
            STANDARD
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          8. Appl No
            021116
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2015-01-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. 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
          10. 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
          11. Appl No
            021116
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission Status Date
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          application number
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          approval interpretation
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          Appl Public Notes
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          products
          1. 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
            1. Prescription
          2. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
            THYRO-TABS
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          3. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
            THYRO-TABS
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          4. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
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            Drug Name
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            Product No
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            Reference Drug
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            Strength
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            marketing status
            1. Prescription
          5. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
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            Drug Name
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            Product No
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            Reference Drug
            1
            Reference Standard
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            Strength
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            marketing status
            1. Prescription
          6. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
            THYRO-TABS
            Form
            TABLET;ORAL
            Product No
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            Reference Drug
            1
            Reference Standard
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            Strength
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            marketing status
            1. Prescription
          7. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
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            Drug Name
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            Form
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            Product No
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            Reference Drug
            1
            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          8. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
            THYRO-TABS
            Form
            TABLET;ORAL
            Product No
            008
            Reference Drug
            1
            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          9. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
            THYRO-TABS
            Form
            TABLET;ORAL
            Product No
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            Reference Drug
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            Reference Standard
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            Strength
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            marketing status
            1. Prescription
          10. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
            THYRO-TABS
            Form
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            Product No
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            Reference Drug
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            Reference Standard
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            Strength
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            marketing status
            1. Prescription
          11. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
            THYRO-TABS
            Form
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            Product No
            011
            Reference Drug
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            Reference Standard
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            Strength
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            marketing status
            1. Prescription
          12. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021116
            Drug Name
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            Form
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            Product No
            012
            Reference Drug
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            Reference Standard
            0
            Strength
            0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. 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 · indication intro context
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        1 INDICATIONS AND USAGE Levothyroxine Sodium Tablets are 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 can
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        are L-thyroxine (T4) indicated
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              1 INDICATIONS AND USAGE Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
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              um Tablets are 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 t
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                    ( 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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                                                  Preserved source evidence · Not medical advice