Nitrofurantion Macrocrystals is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Nitrofurantoin.
| Product ID | 70518-0103_809c26b8-6648-0f66-e053-2a91aa0aa679 |
| NDC | 70518-0103 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Nitrofurantion Macrocrystals |
| Generic Name | Nitrofurantion Macrocrystals |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-01-05 |
| Marketing Category | NDA / NDA |
| Application Number | NDA016620 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | NITROFURANTOIN |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Nitrofurans [CS],Nitrofuran Antibacterial [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2017-01-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA016620 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-01-25 |
| Marketing End Date | 2020-04-01 |
| Marketing Category | NDA |
| Application Number | NDA016620 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-01-05 |
| Marketing End Date | 2020-04-01 |
| Marketing Category | NDA |
| Application Number | NDA016620 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-04-26 |
| Marketing End Date | 2020-04-01 |
| Ingredient | Strength |
|---|---|
| NITROFURANTOIN | 100 mg/1 |
| SPL SET ID: | 46d9e7d7-8007-4d13-be75-b97a9aeea9f4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 12634-415 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 33261-226 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 50090-0314 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 50436-0308 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 55700-295 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 55700-388 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 63187-245 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 63629-6653 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 66267-156 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 68788-6874 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 70518-0103 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 71205-023 | Nitrofurantion Macrocrystals | Nitrofurantion Macrocrystals |
| 71335-0500 | Nitrofurantion Macrocrystals | nitrofurantoin macrocrystals |
| 76413-144 | Nitrofurantoin | Nitrofurantion Macrocrystals |