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LABELS · 2b39b839-0c7c-de03-e063-6294a90a243e

SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT

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
2025-01-08
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS & USAGE When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases For the palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.
Full extracted label fields
application numbers
  1. NDA011856
boxed warning exact
    brand names
    1. SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99b3c99a-79d5-6c54-e053-2a95a90a28bc
    generic names
    1. SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT
    id
    2b39b839-0c7c-de03-e063-6294a90a243e
    indications and usage exact
    1. INDICATIONS & USAGE When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases For the palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.
    indications and usage tables exact
      is original packager
        manufacturer names
        1. HF Acquisition Co LLC, DBA HealthFirst
        matched search terms
        1. cancer
        2. lymphomas
        3. tumor
        package ndcs
        1. 51662-1483-1
        product ndcs
        1. 51662-1483
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAMUSCULAR
        2. INTRAVENOUS
        rxcuis
        1. 1743720
        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
        limit
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        skip
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        sha256
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        url
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        source url
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        spl effective date
        2025-01-08
        spl effective time
        20250108
        spl set id
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        spl version
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        substance names
        1. METHYLPREDNISOLONE SODIUM SUCCINATE
        uniis
        1. LEC9GKY20K
        verification flags
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        Drugs@FDA application source records
        1. application number
          NDA011856
          payload
          all indexed label documents
          1. Appl No
            011856
            Application Docs Date
            2011-10-25 00:00:00
            Application Docs ID
            10784
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            104
            Submission Type
            SUPPL
          2. Appl No
            011856
            Application Docs Date
            2011-10-25 00:00:00
            Application Docs ID
            33061
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            103
            Submission Type
            SUPPL
          3. Appl No
            011856
            Application Docs Date
            2010-07-01 00:00:00
            Application Docs ID
            33062
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            107
            Submission Type
            SUPPL
          4. Appl No
            011856
            Application Docs Date
            2014-07-09 00:00:00
            Application Docs ID
            33063
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            123
            Submission Type
            SUPPL
          5. Appl No
            011856
            Application Docs Date
            2016-09-09 00:00:00
            Application Docs ID
            45262
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            124
            Submission Type
            SUPPL
          6. Appl No
            011856
            Application Docs Date
            2016-09-09 00:00:00
            Application Docs ID
            45263
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            126
            Submission Type
            SUPPL
          7. Appl No
            011856
            Application Docs Date
            2018-04-01 00:00:00
            Application Docs ID
            53571
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            131
            Submission Type
            SUPPL
          8. Appl No
            011856
            Application Docs Date
            2018-07-25 00:00:00
            Application Docs ID
            54963
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            133
            Submission Type
            SUPPL
          9. Appl No
            011856
            Application Docs Date
            2021-06-04 00:00:00
            Application Docs ID
            67701
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            136
            Submission Type
            SUPPL
          10. Appl No
            011856
            Application Docs Date
            2021-11-29 00:00:00
            Application Docs ID
            69419
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            139
            Submission Type
            SUPPL
          11. Appl No
            011856
            Application Docs Date
            2023-12-21 00:00:00
            Application Docs ID
            77105
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            141
            Submission Type
            SUPPL
          12. Appl No
            011856
            Application Docs Date
            2024-06-06 00:00:00
            Application Docs ID
            78675
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            144
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            144
            Submission Status
            AP
            Submission Status Date
            2024-06-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            143
            Submission Status
            AP
            Submission Status Date
            2025-11-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            141
            Submission Status
            AP
            Submission Status Date
            2023-12-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            011856
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            139
            Submission Status
            AP
            Submission Status Date
            2021-10-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            136
            Submission Status
            AP
            Submission Status Date
            2021-05-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            133
            Submission Status
            AP
            Submission Status Date
            2018-07-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            131
            Submission Status
            AP
            Submission Status Date
            2018-03-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            127
            Submission Status
            AP
            Submission Status Date
            2015-08-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            126
            Submission Status
            AP
            Submission Status Date
            2016-09-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            124
            Submission Status
            AP
            Submission Status Date
            2016-09-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            123
            Submission Status
            AP
            Submission Status Date
            2014-07-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            011856
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            122
            Submission Status
            AP
            Submission Status Date
            2014-06-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA011856
          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
          2025-11-04
          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
            011856
            Application Docs Date
            2025-11-07 00:00:00
            Application Docs ID
            84121
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            143
            Submission Type
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          official application record
          Appl No
          011856
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          PHARMACIA AND UPJOHN
          openfda application present
          true
          products
          1. Active Ingredient
            METHYLPREDNISOLONE SODIUM SUCCINATE
            Appl No
            011856
            Drug Name
            SOLU-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 40MG BASE/VIAL
            marketing status
            1. Prescription
          2. Active Ingredient
            METHYLPREDNISOLONE SODIUM SUCCINATE
            Appl No
            011856
            Drug Name
            SOLU-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            004
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 125MG BASE/VIAL
            marketing status
            1. Prescription
          3. Active Ingredient
            METHYLPREDNISOLONE SODIUM SUCCINATE
            Appl No
            011856
            Drug Name
            SOLU-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            005
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 500MG BASE/VIAL
            marketing status
            1. Prescription
          4. Active Ingredient
            METHYLPREDNISOLONE SODIUM SUCCINATE
            Appl No
            011856
            Drug Name
            SOLU-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            006
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 1GM BASE/VIAL
            marketing status
            1. Prescription
          5. Active Ingredient
            METHYLPREDNISOLONE SODIUM SUCCINATE
            Appl No
            011856
            Drug Name
            SOLU-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            007
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 2GM BASE/VIAL
            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. NDA011856
        brand names
        1. SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT
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        INDICATIONS & USAGE When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders Primary or s
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              INDICATIONS & USAGE When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
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              ate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where ap
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              1. SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT
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                    Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
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                                                    es For the palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases Berylliosis, fulminating or disseminated pulmon
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                                                          edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptoma
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                                                                Renal diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
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                                                                lar inflammatory conditions unresponsive to topical corticosteroids. Renal diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spon
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                                                                      ases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.
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                                                                                  Preserved source evidence · Not medical advice