Product NDC: | 52125-650 |
Proprietary Name: | Nitrofurantoin Monohydrate/ Macrocrystalline |
Non Proprietary Name: | Nitrofurantoin Monohydrate/Macrocrystalline |
Active Ingredient(s): | 25; 75 mg/1; mg/1 & nbsp; Nitrofurantoin Monohydrate/Macrocrystalline |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52125-650 |
Labeler Name: | REMEDYREPACK INC. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020064 |
Marketing Category: | NDA |
Start Marketing Date: | 20130624 |
Package NDC: | 52125-650-02 |
Package Description: | 30 CAPSULE in 1 BLISTER PACK (52125-650-02) |
NDC Code | 52125-650-02 |
Proprietary Name | Nitrofurantoin Monohydrate/ Macrocrystalline |
Package Description | 30 CAPSULE in 1 BLISTER PACK (52125-650-02) |
Product NDC | 52125-650 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Nitrofurantoin Monohydrate/Macrocrystalline |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 20130624 |
Marketing Category Name | NDA |
Labeler Name | REMEDYREPACK INC. |
Substance Name | NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE |
Strength Number | 25; 75 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] |