NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Nitrofurantoin; Nitrofurantoin Monohydrate.
| Product ID | 61919-021_4882de1c-7b6a-060d-e054-00144ff8d46c |
| NDC | 61919-021 |
| Product Type | Human Prescription Drug |
| Proprietary Name | NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE |
| Generic Name | Nitrofurantoin Monohydrate |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-02-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020064 |
| Labeler Name | DIRECT RX |
| Substance Name | NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE |
| Active Ingredient Strength | 25 mg/1; mg/1 |
| Pharm Classes | Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2019-07-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA020064 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-08 |
| Marketing Category | NDA |
| Application Number | NDA020064 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-14 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | NDA |
| Application Number | NDA020064 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-08 |
| Ingredient | Strength |
|---|---|
| NITROFURANTOIN | 25 mg/1 |
| SPL SET ID: | 4882de1c-7b69-060d-e054-00144ff8d46c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52959-783 | NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE | NITROFURANTOIN MONOHYDRATE |
| 61919-021 | NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE | NITROFURANTOIN MONOHYDRATE |
| 54348-849 | Nitrofurantoin Mono | NITROFURANTOIN MONOHYDRATE |