NDC 0378-0014

Methotrexate

Methotrexate

Methotrexate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Methotrexate Sodium.

Product ID0378-0014_6f9f237e-62a6-4b99-9d75-e2436df1ee44
NDC0378-0014
Product TypeHuman Prescription Drug
Proprietary NameMethotrexate
Generic NameMethotrexate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1992-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA081235
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMETHOTREXATE SODIUM
Active Ingredient Strength3 mg/1
Pharm ClassesFolate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-0014-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01)
Marketing Start Date1992-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0014-50 [00378001450]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA081235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-04
Marketing End Date2013-07-15

NDC 0378-0014-01 [00378001401]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA081235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1992-05-18

Drug Details

Active Ingredients

IngredientStrength
METHOTREXATE SODIUM2.5 mg/1

OpenFDA Data

SPL SET ID:70c09984-2b36-424f-8b27-3fd0cd4e833d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 105585
  • Pharmacological Class

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