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LABELS · 1d8a4569-8d5f-4451-bd15-20815ea8e693

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
2025-07-29
Captured
2026-09-09T23:37:42.544548+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 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. ( 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
  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=c1b0fbad-5816-4152-ab59-05079e8c2148
generic names
  1. LEVOTHYROXINE SODIUM
id
1d8a4569-8d5f-4451-bd15-20815ea8e693
indications and usage exact
  1. 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. ( 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
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      1. Indications and Usage ( 1 ) 11/2023 Dosage and Administration ( 2.2 , 2.3 ) 11/2023 Warnings and Precautions ( 5.1 , 5.4 ) 11/2023
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      spl effective date
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      substance names
      1. LEVOTHYROXINE SODIUM
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        payload
        all indexed label documents
        1. Appl No
          021116
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          2002-10-24 00:00:00
          Application Docs ID
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          13
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          Application Docs Date
          2019-04-25 00:00:00
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        5. Appl No
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          Application Docs Date
          2023-11-17 00:00:00
          Application Docs ID
          76605
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          0
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          27
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          STANDARD
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          Submission No
          27
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        3. Appl No
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          STANDARD
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        4. Appl No
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          2019-04-23 00:00:00
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        5. Appl No
          021116
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
          2016-05-19 00:00:00
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        6. Appl No
          021116
          Review Priority
          STANDARD
          Submission Class Code ID
          4
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          Submission Status
          AP
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          2015-11-09 00:00:00
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          Submissions Public Notes
        7. Appl No
          021116
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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        8. Appl No
          021116
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
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          AP
          Submission Status Date
          2015-01-13 00:00:00
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          Submissions Public Notes
        9. Appl No
          021116
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          6
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          AP
          Submission Status Date
          2006-03-10 00:00:00
          Submission Type
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          Submissions Public Notes
        10. Appl No
          021116
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          4
          Submission Status
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          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
          15
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          Submissions Public Notes
        application number
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        approval interpretation
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          Application Docs Date
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        Appl No
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        Appl Public Notes
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        openfda application present
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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
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          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
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          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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          Reference Drug
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          Reference Standard
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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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          Reference Drug
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          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
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          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
          1. Prescription
        7. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
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          Drug Name
          THYRO-TABS
          Form
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          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
          1. Prescription
        8. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
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          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
          1. Prescription
        9. 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
          1. Prescription
        10. 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
          1. Prescription
        11. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
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          Drug Name
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          Form
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          Product No
          011
          Reference Drug
          1
          Reference Standard
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          Strength
          0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
          marketing status
          1. Prescription
        12. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
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          Drug Name
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          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

      Source passages and status connections

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      Passage 1 · positive indication candidate
      application numbers
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      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 radio
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          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.
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          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 benefits
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