NDC 70771-1058

Methotrexate

Methotrexate

Methotrexate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Methotrexate.

Product ID70771-1058_9951fcc5-ba19-4d39-acd1-bf5220a2680f
NDC70771-1058
Product TypeHuman Prescription Drug
Proprietary NameMethotrexate
Generic NameMethotrexate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-09
Marketing CategoryANDA / ANDA
Application NumberANDA207812
Labeler NameZydus Lifesciences Limited
Substance NameMETHOTREXATE
Active Ingredient Strength3 mg/1
Pharm ClassesFolate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70771-1058-0

1000 TABLET in 1 BOTTLE (70771-1058-0)
Marketing Start Date2017-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1058-1 [70771105801]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-09

NDC 70771-1058-3 [70771105803]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-09

NDC 70771-1058-2 [70771105802]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-09

NDC 70771-1058-0 [70771105800]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-09

NDC 70771-1058-9 [70771105809]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-09

NDC 70771-1058-7 [70771105807]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-09

NDC 70771-1058-5 [70771105805]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-09

Drug Details

Active Ingredients

IngredientStrength
METHOTREXATE2.5 mg/1

OpenFDA Data

SPL SET ID:59ea7b32-2b6d-4197-92c3-015936f04ebe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 105585

    • 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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