NDC 70518-1398

Methotrexate

Methotrexate

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

Product ID70518-1398_7b0d54a3-0383-0d3c-e053-2991aa0abb0e
NDC70518-1398
Product TypeHuman Prescription Drug
Proprietary NameMethotrexate
Generic NameMethotrexate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-09-04
Marketing CategoryANDA / ANDA
Application NumberANDA207812
Labeler NameREMEDYREPACK INC.
Substance NameMETHOTREXATE
Active Ingredient Strength3 mg/1
Pharm ClassesFolate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1398-0

30 TABLET in 1 BLISTER PACK (70518-1398-0)
Marketing Start Date2018-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1398-3 [70518139803]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-15

NDC 70518-1398-2 [70518139802]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-18

NDC 70518-1398-0 [70518139800]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-04

NDC 70518-1398-1 [70518139801]

Methotrexate TABLET
Marketing CategoryANDA
Application NumberANDA207812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-30

Drug Details

Active Ingredients

IngredientStrength
METHOTREXATE2.5 mg/1

OpenFDA Data

SPL SET ID:d35193e4-0b0e-4a0a-acd8-aa90cc075a2b
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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