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Nitrofurantoin Monohydrate/Macrocrystals
Nitrofurantoin Monohydrate/Macrocrystals - 0378-3422-01 - (Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline)
Drug Information of Nitrofurantoin Monohydrate/Macrocrystals
| Product NDC: | 0378-3422 |
| Proprietary Name: | Nitrofurantoin Monohydrate/Macrocrystals |
| Non Proprietary Name: | Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline |
| Active Ingredient(s): | 25; 75 mg/1; mg/1 & nbsp; Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Nitrofurantoin Monohydrate/Macrocrystals
| Product NDC: | 0378-3422 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076648 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120914 |
Package Information of Nitrofurantoin Monohydrate/Macrocrystals
| Package NDC: | 0378-3422-01 |
| Package Description: | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-01) |
NDC Information of Nitrofurantoin Monohydrate/Macrocrystals
| NDC Code | 0378-3422-01 |
| Proprietary Name | Nitrofurantoin Monohydrate/Macrocrystals |
| Package Description | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-01) |
| Product NDC | 0378-3422 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20120914 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals 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] |
