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LABELS · aca8c79e-06fa-4919-bc65-a2aff5429fde

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
2021-01-01
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: Thyroid hormones, including Levothyroxine Sodium Tablets, USP, either alone or with other therapeutic agents, should not be used for the treatment of obesity 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.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Full extracted label fields
application numbers
  1. NDA021210
boxed warning exact
  1. WARNING: Thyroid hormones, including Levothyroxine Sodium Tablets, USP, either alone or with other therapeutic agents, should not be used for the treatment of obesity 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.
brand names
  1. Levothyroxine Sodium
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f0657d5-3e5c-4249-bfaa-7f5ef1528672
generic names
  1. LEVOTHYROXINE SODIUM
id
aca8c79e-06fa-4919-bc65-a2aff5429fde
indications and usage exact
  1. INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
indications and usage tables exact
    is original packager
      manufacturer names
      1. Proficient Rx LP
      matched search terms
      1. cancer
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      1. 71205-221-30
      2. 71205-221-60
      3. 71205-221-90
      4. 71205-222-30
      5. 71205-222-60
      6. 71205-222-90
      product ndcs
      1. 71205-221
      2. 71205-222
      product types
      1. HUMAN PRESCRIPTION DRUG
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        spl effective date
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        spl effective time
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        substance names
        1. LEVOTHYROXINE SODIUM
        uniis
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        1. application number
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          payload
          all indexed label documents
          1. Appl No
            021210
            Application Docs Date
            2000-08-21 00:00:00
            Application Docs ID
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            Application Docs Type ID
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            1
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            Submission No
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            Submission Type
            SUPPL
          3. Appl No
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            Application Docs Date
            2018-12-12 00:00:00
            Application Docs ID
            56720
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          all submission records
          1. 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
          2. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
            1
            Submission Status
            AP
            Submission Status Date
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            SUPPL
            Submissions Public Notes
          3. Appl No
            021210
            Review Priority
            UNKNOWN
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            Submission No
            2
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            2004-06-23 00:00:00
            Submission Type
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            Submissions Public Notes
          4. Appl No
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            Review Priority
            UNKNOWN
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            Submission No
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            Submission Status
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            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
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            Review Priority
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            Submission Class Code ID
            4
            Submission No
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          6. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
            6
            Submission Status
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            Submission Status Date
            2009-09-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
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            Submission Status Date
            2018-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
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            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
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          current indication status
          not_reconciled
          has approved submission record
          true
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          latest posted label documents
          1. Appl No
            021210
            Application Docs Date
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            Application Docs ID
            56720
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
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            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
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          Sponsor Name
          STEVENS J
          openfda application present
          true
          products
          1. 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
            1. Prescription
          2. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            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
            021210
            Drug Name
            UNITHROID
            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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            Form
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            Product No
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            Reference Drug
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            Reference Standard
            0
            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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            Form
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            Product No
            005
            Reference Drug
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            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          6. 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
            1. Prescription
          7. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            007
            Reference Drug
            1
            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          8. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
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            Reference Drug
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            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          9. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
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            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            009
            Reference Drug
            1
            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          10. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
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            Form
            TABLET;ORAL
            Product No
            010
            Reference Drug
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            Reference Standard
            0
            Strength
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            marketing status
            1. Prescription
          11. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
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            Drug Name
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            Form
            TABLET;ORAL
            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
            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
            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 · unclassified context
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        INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional
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              INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.
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              s: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or w
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                    Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism.
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                    during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute o
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                        Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
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                        ult from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
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                              Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, 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