| NDC Code | 55289-822-10 |
|---|
| Package Description | 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-10) |
|---|
| Product NDC | 55289-822 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Nitrofurantoin Monohydrate/ Macrocrystalline |
|---|
| Non-Proprietary Name | Nitrofurantoin Monohydrate/macrocrystalline |
|---|
| Dosage Form | CAPSULE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20110525 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA020064 |
|---|
| Manufacturer | PD-Rx Pharmaceuticals, Inc. |
|---|
| Substance Name | NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE |
|---|
| Strength | 25; 75 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS] |
|---|