| NDC Code | 69189-3658-1 |
| Package Description | 1 CAPSULE in 1 DOSE PACK (69189-3658-1) |
| Product NDC | 69189-3658 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Nitrofurantoin Monohydrate Macrocrystals |
| Non-Proprietary Name | Nitrofurantoin Monohydrate Macrocrystals |
| Dosage Form | CAPSULE |
| Usage | ORAL |
| Start Marketing Date | 20160328 |
| Marketing Category Name | ANDA |
| Application Number | ANDA202250 |
| Manufacturer | Avera McKennan Hospital |
| Substance Name | NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN |
| Strength | 75; 25 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] |