"0378-3422-05" National Drug Code (NDC)

Nitrofurantoin Monohydrate/macrocrystals 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3422-05
Package Description500 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-05)
Product NDC0378-3422
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNitrofurantoin Monohydrate/macrocrystals
Non-Proprietary NameNitrofurantoin Monohydrate And Nitrofurantoin, Macrocrystalline
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20120914
Marketing Category NameANDA
Application NumberANDA076648
ManufacturerMylan Pharmaceuticals Inc.
Substance NameNITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Strength25; 75
Strength Unitmg/1; mg/1
Pharmacy ClassesNitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient]

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