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NDC 43386-0450-11 Nitrofurantoin 25 mg/5mL Details
Nitrofurantoin 25 mg/5mL
Nitrofurantoin is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is NITROFURANTOIN.
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: 43386-0450-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nitrofurantoin
Product Information
| NDC | 43386-0450 |
|---|---|
| Product ID | 43386-450_361dd255-19ba-453f-9b68-ade3185ff390 |
| Associated GPIs | 16800050001810 |
| GCN Sequence Number | 009434 |
| GCN Sequence Number Description | nitrofurantoin ORAL SUSP 25 MG/5 ML ORAL |
| HIC3 | W2F |
| HIC3 Description | NITROFURAN DERIVATIVES ANTIBACTERIAL AGENTS |
| GCN | 41870 |
| HICL Sequence Number | 004089 |
| HICL Sequence Number Description | NITROFURANTOIN |
| Brand/Generic | Generic |
| Proprietary Name | Nitrofurantoin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Nitrofurantoin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/5mL |
| Substance Name | NITROFURANTOIN |
| Labeler Name | Lupin Pharmaceuticals,Inc. |
| Pharmaceutical Class | Nitrofuran Antibacterial [EPC], Nitrofurans [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201693 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43386-0450-11 (43386045011)
| NDC Package Code | 43386-450-11 |
|---|---|
| Billing NDC | 43386045011 |
| Package | 1 BOTTLE in 1 CARTON (43386-450-11) / 230 mL in 1 BOTTLE |
| Marketing Start Date | 2015-05-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |