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LABELS · b85ab7fa-ba96-43cd-b736-44b3924e644c

Synthroid

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
2024-02-20
Captured
2026-09-09T23:37:58.719708+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 SYNTHROID, 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 SYNTHROID , 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 SYNTHROID is 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 SYNTHROID is 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 SYNTHROID 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 SYNTHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.1 )]. SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. SYNTHROID is a 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. NDA021402
boxed warning exact
  1. WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including SYNTHROID, 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 SYNTHROID , 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. Synthroid
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc
generic names
  1. LEVOTHYROXINE SODIUM
id
b85ab7fa-ba96-43cd-b736-44b3924e644c
indications and usage exact
  1. 1 INDICATIONS AND USAGE Hypothyroidism SYNTHROID is 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 SYNTHROID is 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 SYNTHROID 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 SYNTHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.1 )]. SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. SYNTHROID is a 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
    is original packager
    1. true
    manufacturer names
    1. AbbVie Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 0074-4341-13
    2. 0074-4341-90
    3. 0074-4341-19
    4. 0074-4341-72
    5. 0074-4552-13
    6. 0074-4552-90
    7. 0074-4552-19
    8. 0074-4552-11
    9. 0074-4552-71
    10. 0074-4552-72
    11. 0074-5182-13
    12. 0074-5182-90
    product ndcs
    1. 0074-3727
    2. 0074-4341
    3. 0074-4552
    4. 0074-5182
    5. 0074-6594
    6. 0074-6624
    7. 0074-9296
    8. 0074-7068
    9. 0074-7069
    10. 0074-7070
    11. 0074-7148
    12. 0074-7149
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Dosage and Administration, Important Considerations for Dosing ( 2.2 ) 2/2024 Dosage and Administration, Monitoring TSH and/or Thyroxine (T4) Levels ( 2.4 ) 2/2024
    record type
    complete_spl_indications_section_candidate
    routes
    1. ORAL
    rxcuis
    1. 892246
    2. 892251
    3. 892255
    4. 966158
    5. 966171
    6. 966185
    7. 966191
    8. 966201
    9. 966205
    10. 966218
    11. 966220
    12. 966221
    source batch
    file
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    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.
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    2026-09-09
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    sha256
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    url
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    source url
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    spl effective date
    2024-02-20
    spl effective time
    20240220
    spl set id
    1e11ad30-1041-4520-10b0-8f9d30d30fcc
    spl version
    1537
    substance names
    1. LEVOTHYROXINE SODIUM
    uniis
    1. 9J765S329G
    verification flags
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    Drugs@FDA application source records
    1. application number
      NDA021402
      payload
      all indexed label documents
      1. Appl No
        021402
        Application Docs Date
        2002-07-24 00:00:00
        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        021402
        Application Docs Date
        2008-07-15 00:00:00
        Application Docs ID
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        Application Docs Type ID
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        Submission No
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        Submission Type
        SUPPL
      3. Appl No
        021402
        Application Docs Date
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        Application Docs ID
        15373
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        20
        Submission Type
        SUPPL
      4. Appl No
        021402
        Application Docs Date
        2008-06-05 00:00:00
        Application Docs ID
        36822
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      5. Appl No
        021402
        Application Docs Date
        2017-02-24 00:00:00
        Application Docs ID
        47324
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        24
        Submission Type
        SUPPL
      6. Appl No
        021402
        Application Docs Date
        2017-02-24 00:00:00
        Application Docs ID
        47325
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        28
        Submission Type
        SUPPL
      7. Appl No
        021402
        Application Docs Date
        2020-07-16 00:00:00
        Application Docs ID
        63938
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        34
        Submission Type
        SUPPL
      8. Appl No
        021402
        Application Docs Date
        2022-08-31 00:00:00
        Application Docs ID
        71979
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        36
        Submission Type
        SUPPL
      9. Appl No
        021402
        Application Docs Date
        2024-02-20 00:00:00
        Application Docs ID
        77590
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        38
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        38
        Submission Status
        AP
        Submission Status Date
        2024-02-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        36
        Submission Status
        AP
        Submission Status Date
        2022-08-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        34
        Submission Status
        AP
        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      4. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        30
        Submission Status
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        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      5. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        29
        Submission Status
        AP
        Submission Status Date
        2015-11-25 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        28
        Submission Status
        AP
        Submission Status Date
        2017-02-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        27
        Submission Status
        AP
        Submission Status Date
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        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        26
        Submission Status
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        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      9. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        25
        Submission Status
        AP
        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      10. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        24
        Submission Status
        AP
        Submission Status Date
        2017-02-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        021402
        Review Priority
        UNKNOWN
        Submission Class Code ID
        3
        Submission No
        20
        Submission Status
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        Submission Status Date
        2011-01-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        021402
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        17
        Submission Status
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        Submission Status Date
        2008-07-14 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
      NDA021402
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2024-02-20
      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        021402
        Application Docs Date
        2024-02-20 00:00:00
        Application Docs ID
        77590
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        38
        Submission Type
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      official application record
      Appl No
      021402
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
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      openfda application present
      true
      products
      1. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        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
        021402
        Drug Name
        SYNTHROID
        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
        1. Prescription
      3. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        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
        1. Prescription
      4. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        Form
        TABLET;ORAL
        Product No
        004
        Reference Drug
        1
        Reference Standard
        0
        Strength
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        marketing status
        1. Prescription
      5. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        Form
        TABLET;ORAL
        Product No
        005
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
        marketing status
        1. Prescription
      6. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        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
        021402
        Drug Name
        SYNTHROID
        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
        1. Prescription
      8. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        Form
        TABLET;ORAL
        Product No
        008
        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
      9. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        Form
        TABLET;ORAL
        Product No
        009
        Reference Drug
        1
        Reference Standard
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        Strength
        0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
        marketing status
        1. Prescription
      10. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        Form
        TABLET;ORAL
        Product No
        010
        Reference Drug
        1
        Reference Standard
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        Strength
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        marketing status
        1. Prescription
      11. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        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
        1. Prescription
      12. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021402
        Drug Name
        SYNTHROID
        Form
        TABLET;ORAL
        Product No
        012
        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

    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
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    1 INDICATIONS AND USAGE Hypothyroidism SYNTHROID is 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 SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in t
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      ICATIONS AND USAGE Hypothyroidism SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacemen
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                                        1537
                                        structured fields status
                                        not_extracted_no_values_inferred_from_mentions
                                        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
                                        not_applicable

                                        Preserved source evidence · Not medical advice