"82497-012-04" National Drug Code (NDC)

Otrexup 4 SYRINGE in 1 CARTON (82497-012-04) / .4 mL in 1 SYRINGE (82497-012-02)
(Otter Pharmaceuticals, LLC)

NDC Code82497-012-04
Package Description4 SYRINGE in 1 CARTON (82497-012-04) / .4 mL in 1 SYRINGE (82497-012-02)
Product NDC82497-012
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOtrexup
Non-Proprietary NameMethotrexate
Dosage FormINJECTION, SOLUTION
UsageSUBCUTANEOUS
Start Marketing Date20240925
Marketing Category NameNDA
Application NumberNDA204824
ManufacturerOtter Pharmaceuticals, LLC
Substance NameMETHOTREXATE
Strength12.5
Strength Unitmg/.4mL
Pharmacy ClassesFolate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]

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