"0378-3422-01" National Drug Code (NDC)

Nitrofurantoin Monohydrate/macrocrystals 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3422-01
Package Description100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-01)
Product NDC0378-3422
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNitrofurantoin Monohydrate/macrocrystals
Non-Proprietary NameNitrofurantoin Monohydrate And Nitrofurantoin, Macrocrystalline
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20040323
Marketing Category NameANDA
Application NumberANDA076648
ManufacturerMylan Pharmaceuticals Inc.
Substance NameNITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Strength75; 25
Strength Unitmg/1; mg/1
Pharmacy ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]

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