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LABELS · fc5f7c1f-53da-b350-e053-6394a90a5e75

SOLU-MEDROL

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
2023-05-23
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND 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, 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
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dd2bfa31-9eae-2baa-e053-2a95a90a9db7
    generic names
    1. METHYLPREDNISOLONE SODIUM SUCCINATE
    id
    fc5f7c1f-53da-b350-e053-6394a90a5e75
    indications and usage exact
    1. INDICATIONS AND 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, 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. Medical Purchasing Solutions, LLC
        matched search terms
        1. cancer
        2. lymphomas
        3. tumor
        package ndcs
        1. 71872-7085-1
        product ndcs
        1. 71872-7085
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
          record type
          complete_spl_indications_section_candidate
          routes
          1. INTRAMUSCULAR
          2. INTRAVENOUS
          rxcuis
          1. 207191
          2. 311659
          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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          sha256
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          url
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          source url
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          spl effective date
          2023-05-23
          spl effective time
          20230523
          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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          4. not_identified_as_original_packager
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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
              SUPPL
            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
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          brand names
          1. SOLU-MEDROL
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          exact text
          INDICATIONS AND 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, 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 AND 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, serum sickness, transfusion reactions.
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                Source null
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                Source null
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                allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, 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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                      Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
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                                                            Ophthalmic diseases Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
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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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                                                                        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