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LABELS · 95b8b8da-da4e-4bba-9038-3cf65f3d5c1a

Methotrexate

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
2025-06-10
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS • Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females and males of reproductive potential to use effective contraception [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . • Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.2) ]. • Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available [see Dosage and Administration (2.1) and Warnings and Precautions (5.3) ]. • Other serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, kidneys, liver, nervous system, gastrointestinal tract, lungs, and skin. Withhold or discontinue Methotrexate Injection as appropriate [see Warnings and Precautions (5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11) ]. WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS See full prescribing information for complete boxed warning . • Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. Use in non-neoplastic diseases is contraindicated during pregnancy. Advise females and males of reproductive potential to use effective contraception during and after treatment with Methotrexate Injection. ( 4 , 5.1 , 8.1 , 8.3 ) • Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis. ( 4 , 5.2 ) • Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants, and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available. ( 2.1 , 5.3 ) • Other serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, kidneys, liver, nervous system, gastrointestinal tract, lungs, and skin. Withhold or discontinue Methotrexate Injection as appropriate. ( 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Methotrexate Injection is a folate analog metabolic inhibitor indicated for: • The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. ( 1.1 ) o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. ( 1.2 ) o Treatment of adult and pediatric patients with non-Hodgkin lymphoma. ( 1.3 ) o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. ( 1.4 ) o Treatment of adults with breast cancer as part of a combination chemotherapy regimen. ( 1.5 ) o Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. ( 1.6 ) o Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. ( 1.7 ) • Treatment of adults with rheumatoid arthritis (RA). ( 1.8 ) • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). ( 1.9 ) • Treatment of adults with severe psoriasis. ( 1.10 ) 1.1 Acute Lymphoblastic Leukemia Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen. 1.2 Meningeal Leukemia: Prophylaxis and Treatment Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients. 1.3 Non-Hodgkin Lymphoma Methotrexate Injection is indicated for the treatment of adults and pediatric patients with non-Hodgkin lymphoma. 1.4 Osteosarcoma Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. 1.5 Breast Cancer Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen. 1.6 Squamous Cell Carcinoma of the Head and Neck Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single agent. 1.7 Gestational Trophoblastic Neoplasia Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen. 1.8 Rheumatoid Arthritis Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA). 1.9 Polyarticular Juvenile Idiopathic Arthritis Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). 1.10 Psoriasis Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.
Full extracted label fields
application numbers
  1. NDA011719
boxed warning exact
  1. WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS • Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females and males of reproductive potential to use effective contraception [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . • Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.2) ]. • Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available [see Dosage and Administration (2.1) and Warnings and Precautions (5.3) ]. • Other serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, kidneys, liver, nervous system, gastrointestinal tract, lungs, and skin. Withhold or discontinue Methotrexate Injection as appropriate [see Warnings and Precautions (5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11) ]. WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS See full prescribing information for complete boxed warning . • Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. Use in non-neoplastic diseases is contraindicated during pregnancy. Advise females and males of reproductive potential to use effective contraception during and after treatment with Methotrexate Injection. ( 4 , 5.1 , 8.1 , 8.3 ) • Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis. ( 4 , 5.2 ) • Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants, and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available. ( 2.1 , 5.3 ) • Other serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, kidneys, liver, nervous system, gastrointestinal tract, lungs, and skin. Withhold or discontinue Methotrexate Injection as appropriate. ( 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 )
brand names
  1. Methotrexate
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d63ba29-b692-41b4-87e8-351265c8273f
generic names
  1. METHOTREXATE
id
95b8b8da-da4e-4bba-9038-3cf65f3d5c1a
indications and usage exact
  1. 1 INDICATIONS AND USAGE Methotrexate Injection is a folate analog metabolic inhibitor indicated for: • The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. ( 1.1 ) o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. ( 1.2 ) o Treatment of adult and pediatric patients with non-Hodgkin lymphoma. ( 1.3 ) o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. ( 1.4 ) o Treatment of adults with breast cancer as part of a combination chemotherapy regimen. ( 1.5 ) o Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. ( 1.6 ) o Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. ( 1.7 ) • Treatment of adults with rheumatoid arthritis (RA). ( 1.8 ) • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). ( 1.9 ) • Treatment of adults with severe psoriasis. ( 1.10 ) 1.1 Acute Lymphoblastic Leukemia Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen. 1.2 Meningeal Leukemia: Prophylaxis and Treatment Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients. 1.3 Non-Hodgkin Lymphoma Methotrexate Injection is indicated for the treatment of adults and pediatric patients with non-Hodgkin lymphoma. 1.4 Osteosarcoma Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. 1.5 Breast Cancer Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen. 1.6 Squamous Cell Carcinoma of the Head and Neck Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single agent. 1.7 Gestational Trophoblastic Neoplasia Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen. 1.8 Rheumatoid Arthritis Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA). 1.9 Polyarticular Juvenile Idiopathic Arthritis Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). 1.10 Psoriasis Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Hospira, Inc.
    matched search terms
    1. cancer
    2. carcinoma
    3. lymphoma
    4. leukemia
    package ndcs
    1. 61703-350-37
    2. 61703-350-38
    3. 61703-408-41
    product ndcs
    1. 61703-350
    2. 61703-408
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Warnings and Precautions ( 5.11 ) 05/2025
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAMUSCULAR
    2. INTRAVENOUS
    3. SUBCUTANEOUS
    4. INTRATHECAL
    rxcuis
    1. 1655956
    2. 1946772
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00500.json
    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
    100
    skip
    500
    total
    830
    sha256
    424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
    url
    https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
    source url
    https://api.fda.gov/drug/label.json?search=id%3A%2295b8b8da-da4e-4bba-9038-3cf65f3d5c1a%22
    spl effective date
    2025-06-10
    spl effective time
    20250610
    spl set id
    0d63ba29-b692-41b4-87e8-351265c8273f
    spl version
    19
    substance names
    1. METHOTREXATE SODIUM
    uniis
    1. 3IG1E710ZN
    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
      NDA011719
      payload
      all indexed label documents
      1. Appl No
        011719
        Application Docs Date
        2004-02-03 00:00:00
        Application Docs ID
        10774
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        106
        Submission Type
        SUPPL
      2. Appl No
        011719
        Application Docs Date
        2015-11-25 00:00:00
        Application Docs ID
        10775
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        122
        Submission Type
        SUPPL
      3. Appl No
        011719
        Application Docs Date
        2011-11-04 00:00:00
        Application Docs ID
        33054
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        117
        Submission Type
        SUPPL
      4. Appl No
        011719
        Application Docs Date
        2018-03-16 00:00:00
        Application Docs ID
        53041
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        126
        Submission Type
        SUPPL
      5. Appl No
        011719
        Application Docs Date
        2018-05-07 00:00:00
        Application Docs ID
        54036
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        125
        Submission Type
        SUPPL
      6. Appl No
        011719
        Application Docs Date
        2021-04-19 00:00:00
        Application Docs ID
        66921
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        131
        Submission Type
        SUPPL
      7. Appl No
        011719
        Application Docs Date
        2022-05-03 00:00:00
        Application Docs ID
        70913
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        135
        Submission Type
        SUPPL
      8. Appl No
        011719
        Application Docs Date
        2023-11-17 00:00:00
        Application Docs ID
        76607
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        138
        Submission Type
        SUPPL
      9. Appl No
        011719
        Application Docs Date
        2024-07-16 00:00:00
        Application Docs ID
        79104
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        136
        Submission Type
        SUPPL
      10. Appl No
        011719
        Application Docs Date
        2025-05-30 00:00:00
        Application Docs ID
        82358
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        142
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        70
        Submission Status
        AP
        Submission Status Date
        1987-03-19 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        63
        Submission Status
        AP
        Submission Status Date
        1983-04-08 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        011719
        Review Priority
        Submission Class Code ID
        3
        Submission No
        62
        Submission Status
        AP
        Submission Status Date
        1982-08-24 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        59
        Submission Status
        AP
        Submission Status Date
        1983-04-08 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        58
        Submission Status
        AP
        Submission Status Date
        1982-03-31 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        011719
        Review Priority
        Submission Class Code ID
        3
        Submission No
        57
        Submission Status
        AP
        Submission Status Date
        1982-03-31 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        56
        Submission Status
        AP
        Submission Status Date
        1981-12-07 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        54
        Submission Status
        AP
        Submission Status Date
        1981-05-11 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        53
        Submission Status
        AP
        Submission Status Date
        1980-12-03 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        52
        Submission Status
        AP
        Submission Status Date
        1980-02-29 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        51
        Submission Status
        AP
        Submission Status Date
        1979-10-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        011719
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        50
        Submission Status
        AP
        Submission Status Date
        1980-06-11 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA011719
      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
      2025-05-28
      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
        011719
        Application Docs Date
        2025-05-30 00:00:00
        Application Docs ID
        82358
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        142
        Submission Type
        SUPPL
      official application record
      Appl No
      011719
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      HOSPIRA
      openfda application present
      true
      products
      1. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      2. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM
        Form
        INJECTABLE;INJECTION
        Product No
        003
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      3. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM
        Form
        INJECTABLE;INJECTION
        Product No
        004
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      4. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM
        Form
        INJECTABLE;INJECTION
        Product No
        005
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      5. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM
        Form
        INJECTABLE;INJECTION
        Product No
        006
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      6. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE LPF
        Form
        INJECTABLE;INJECTION
        Product No
        007
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      7. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM PRESERVATIVE FREE
        Form
        INJECTABLE;INJECTION
        Product No
        009
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      8. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM
        Form
        INJECTABLE;INJECTION
        Product No
        010
        Reference Drug
        1
        Reference Standard
        1
        Strength
        EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
        marketing status
        1. Prescription
      9. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE PRESERVATIVE FREE
        Form
        INJECTABLE;INJECTION
        Product No
        011
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
      10. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE SODIUM PRESERVATIVE FREE
        Form
        INJECTABLE;INJECTION
        Product No
        012
        Reference Drug
        1
        Reference Standard
        1
        Strength
        EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
        marketing status
        1. Prescription
      11. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        011719
        Drug Name
        METHOTREXATE PRESERVATIVE FREE
        Form
        INJECTABLE;INJECTION
        Product No
        013
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        marketing status
        1. Discontinued
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        Reference Drug
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        Reference Standard
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                                                                                                                Preserved source evidence · Not medical advice