NDC Code | 0378-3422-05 |
Package Description | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-05) |
Product NDC | 0378-3422 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Nitrofurantoin Monohydrate/macrocrystals |
Non-Proprietary Name | Nitrofurantoin Monohydrate And Nitrofurantoin, Macrocrystalline |
Dosage Form | CAPSULE |
Usage | ORAL |
Start Marketing Date | 20120914 |
Marketing Category Name | ANDA |
Application Number | ANDA076648 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE |
Strength | 25; 75 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] |