NDC 0703-3671

Methotrexate

Methotrexate

Methotrexate is a Intra-arterial; Intramuscular; Intrathecal; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Methotrexate Sodium.

Product ID0703-3671_0e9e8fcc-07ad-449a-a312-1dcba2c96abe
NDC0703-3671
Product TypeHuman Prescription Drug
Proprietary NameMethotrexate
Generic NameMethotrexate
Dosage FormInjection, Solution
Route of AdministrationINTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Marketing Start Date2013-01-30
Marketing CategoryANDA / ANDA
Application NumberANDA040843
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameMETHOTREXATE SODIUM
Active Ingredient Strength25 mg/mL
Pharm ClassesFolate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0703-3671-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-01) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-3671-91 [00703367191]

Methotrexate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040843
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-01-30
Marketing End Date2017-10-31

NDC 0703-3671-93 [00703367193]

Methotrexate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040843
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-01-30
Marketing End Date2017-10-31

NDC 0703-3671-01 [00703367101]

Methotrexate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040843
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-07-31

NDC 0703-3671-03 [00703367103]

Methotrexate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040843
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-07-31
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
METHOTREXATE SODIUM25 mg/mL

OpenFDA Data

SPL SET ID:346ec9ce-dc98-4a55-b55e-d3af11f2d703
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1655959
  • 1655960
  • 1655956
  • Pharmacological Class

    • Folate Analog Metabolic Inhibitor [EPC]
    • Folic Acid Metabolism Inhibitors [MoA]

    NDC Crossover Matching brand name "Methotrexate" or generic name "Methotrexate"

    NDCBrand NameGeneric Name
    0143-9367MethotrexateMethotrexate
    0143-9516MethotrexateMethotrexate
    0143-9517MethotrexateMethotrexate
    0143-9518MethotrexateMethotrexate
    0143-9519MethotrexateMethotrexate
    0143-9830MethotrexateMethotrexate
    0378-0014Methotrexatemethotrexate
    0555-0572MethotrexateMethotrexate
    0703-3671MethotrexateMethotrexate
    0703-3675MethotrexateMethotrexate
    0703-3678MethotrexateMethotrexate
    68382-775MethotrexateMethotrexate
    69238-1423MethotrexateMethotrexate
    70518-0223METHOTREXATEMETHOTREXATE
    70518-1251MethotrexateMethotrexate
    70518-1398MethotrexateMethotrexate
    70771-1058MethotrexateMethotrexate
    71335-0782MethotrexateMethotrexate
    16729-277MethotrexateMethotrexate
    21695-111MethotrexateMethotrexate
    42291-594MethotrexateMethotrexate
    42254-110METHOTREXATEMETHOTREXATE
    43063-439MethotrexateMethotrexate
    47335-235MethotrexateMethotrexate
    50090-0294METHOTREXATEMETHOTREXATE
    50090-2345MethotrexateMethotrexate
    50090-3418MethotrexateMethotrexate
    51079-670MethotrexateMethotrexate
    51407-121MethotrexateMethotrexate
    61703-350MethotrexateMethotrexate
    61703-408MethotrexateMethotrexate
    63323-122MethotrexateMethotrexate
    63323-123MethotrexateMethotrexate
    66336-338METHOTREXATEMETHOTREXATE
    67253-320METHOTREXATEMETHOTREXATE
    67457-480MethotrexateMethotrexate
    67457-466MethotrexateMethotrexate
    71335-1118MethotrexateMethotrexate

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