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NDC 43063-0582-10 Nitrofurantoin Monohydrate/ Macrocrystalline 25; 75 mg/1; mg/1 Details
Nitrofurantoin Monohydrate/ Macrocrystalline 25; 75 mg/1; mg/1
Nitrofurantoin Monohydrate/ Macrocrystalline is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE.
MedlinePlus Drug Summary
Nitrofurantoin is used to treat urinary tract infections. Nitrofurantoin is in a class of medications called antibiotics. It works by killing bacteria that cause infection. Antibiotics such as nitrofurantoin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 43063-0582-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nitrofurantoin
Product Information
| NDC | 43063-0582 |
|---|---|
| Product ID | 43063-582_0647763a-b326-8722-e063-6394a90aae96 |
| Associated GPIs | 16800050150120 |
| GCN Sequence Number | 016598 |
| GCN Sequence Number Description | nitrofurantoin monohyd/m-cryst CAPSULE 100 MG ORAL |
| HIC3 | W2F |
| HIC3 Description | NITROFURAN DERIVATIVES ANTIBACTERIAL AGENTS |
| GCN | 49001 |
| HICL Sequence Number | 006322 |
| HICL Sequence Number Description | NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS |
| Brand/Generic | Generic |
| Proprietary Name | Nitrofurantoin Monohydrate/ Macrocrystalline |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Nitrofurantoin Monohydrate/Macrocrystalline |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 25; 75 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020064 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0582-10 (43063058210)
| NDC Package Code | 43063-582-10 |
|---|---|
| Billing NDC | 43063058210 |
| Package | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-582-10) |
| Marketing Start Date | 2020-02-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |