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LABELS · 4ddc8742-bf50-baa5-e063-6294a90a56eb

Tirosint

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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
2026-03-25
Captured
2026-09-09T23:37:47.659725+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 TIROSINT, 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 TIROSINT, 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 INDICATION AND USAGE TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: 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 ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: TIROSINT 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 TIROSINT may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. TIROSINT is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
Full extracted label fields
application numbers
  1. NDA021924
boxed warning exact
  1. WARNING: NOT FOR TREATMENT OF OBESITY or FOR WEIGHT LOSS Thyroid hormones, including TIROSINT, 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 TIROSINT, 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. Tirosint
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7a7ade79-0165-4e31-b84e-667416c00c7e
generic names
  1. LEVOTHYROXINE SODIUM
id
4ddc8742-bf50-baa5-e063-6294a90a56eb
indications and usage exact
  1. 1 INDICATION AND USAGE TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: 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 ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: TIROSINT 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 TIROSINT may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. TIROSINT is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. IBSA Pharma Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 71858-0013-4
    2. 71858-0013-1
    3. 71858-0013-2
    4. 71858-0012-4
    5. 71858-0012-1
    6. 71858-0012-2
    7. 71858-0005-4
    8. 71858-0005-1
    9. 71858-0005-2
    10. 71858-0010-4
    11. 71858-0010-1
    12. 71858-0010-2
    product ndcs
    1. 71858-0005
    2. 71858-0013
    3. 71858-0012
    4. 71858-0010
    5. 71858-0015
    6. 71858-0020
    7. 71858-0025
    8. 71858-0030
    9. 71858-0035
    10. 71858-0040
    11. 71858-0045
    12. 71858-0050
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    record type
    complete_spl_indications_section_candidate
    routes
    1. ORAL
    rxcuis
    1. 905451
    2. 905453
    3. 905455
    4. 905457
    5. 905458
    6. 905460
    7. 905462
    8. 905464
    9. 966404
    10. 966405
    11. 966406
    12. 966407
    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.
    last updated
    2026-09-09
    results
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    830
    sha256
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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%224ddc8742-bf50-baa5-e063-6294a90a56eb%22
    spl effective date
    2026-03-25
    spl effective time
    20260325
    spl set id
    7a7ade79-0165-4e31-b84e-667416c00c7e
    spl version
    13
    substance names
    1. LEVOTHYROXINE SODIUM
    uniis
    1. 9J765S329G
    verification flags
    1. oncology_keyword_candidate_not_clinically_classified
    2. spl_text_not_verified_identical_to_latest_approved_label
    3. individual_indications_not_split_or_reconciled
    Drugs@FDA application source records
    1. application number
      NDA021924
      payload
      all indexed label documents
      1. Appl No
        021924
        Application Docs Date
        2006-10-18 00:00:00
        Application Docs ID
        16575
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        021924
        Application Docs Date
        2007-12-27 00:00:00
        Application Docs ID
        16576
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        2
        Submission Type
        SUPPL
      3. Appl No
        021924
        Application Docs Date
        2012-03-06 00:00:00
        Application Docs ID
        37883
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        6
        Submission Type
        SUPPL
      4. Appl No
        021924
        Application Docs Date
        2017-12-11 00:00:00
        Application Docs ID
        50648
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        13
        Submission Type
        SUPPL
      5. Appl No
        021924
        Application Docs Date
        2022-10-31 00:00:00
        Application Docs ID
        72501
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        021924
        Review Priority
        STANDARD
        Submission Class Code ID
        12
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2006-10-13 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        021924
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2008-01-01 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        021924
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2007-12-17 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        021924
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2012-03-04 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        021924
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2013-07-11 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        021924
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2017-04-25 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        021924
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2017-12-08 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        021924
        Review Priority
        N/A
        Submission Class Code ID
        4
        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2022-06-22 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA021924
      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
      2022-06-22
      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
        021924
        Application Docs Date
        2022-10-31 00:00:00
        Application Docs ID
        72501
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      official application record
      Appl No
      021924
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      IBSA
      openfda application present
      true
      products
      1. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        002
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.025MG
        marketing status
        1. Prescription
      2. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        003
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.05MG
        marketing status
        1. Prescription
      3. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        004
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.075MG
        marketing status
        1. Prescription
      4. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        005
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.1MG
        marketing status
        1. Prescription
      5. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
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        Form
        CAPSULE;ORAL
        Product No
        006
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.125MG
        marketing status
        1. Prescription
      6. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        007
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.15MG
        marketing status
        1. Prescription
      7. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        008
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.112MG
        marketing status
        1. Prescription
      8. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        009
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.137MG
        marketing status
        1. Prescription
      9. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        010
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.088MG
        marketing status
        1. Prescription
      10. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        011
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.175MG
        marketing status
        1. Prescription
      11. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        012
        Reference Drug
        1
        Reference Standard
        1
        Strength
        0.2MG
        marketing status
        1. Prescription
      12. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        021924
        Drug Name
        TIROSINT
        Form
        CAPSULE;ORAL
        Product No
        013
        Reference Drug
        1
        Reference Standard
        0
        Strength
        0.013MG
        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
    1. NDA021924
    brand names
    1. Tirosint
    classification reasons
    1. explicit_positive_indication_predicate
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    clinical review status
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    exact text
    1 INDICATION AND USAGE TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: 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 ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years
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    qualifier mentions
    1. context exact
      CATION AND USAGE TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidi
      kind
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      polarity
      not_inferred
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    2. context exact
      USAGE TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidism - As replacement the
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      polarity
      not_inferred
      span
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      end exclusive
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    3. context exact
      -thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidism - As replacement therapy in primary (t
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      polarity
      not_inferred
      span
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    4. context exact
      hyroidism TIROSINT is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyr
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      polarity
      not_inferred
      span
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    5. context exact
      IROSINT is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pitu
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      polarity
      not_inferred
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    6. context exact
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                        Preserved source evidence · Not medical advice