Prescription drug · ANDA
Nitrofurantoin NDC 70518-4244
Nitrofurantoin 100 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4244-0 | 70518424400 | 30 CAPSULE in 1 BLISTER PACK (70518-4244-0)Marketed from Dec 20, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nitrofurantoin
- Generic name (nonproprietary)
- nitrofurantoin
- Active ingredients
- Nitrofurantoin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211935
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 70518-4244_5a6e614b-9ae9-9719-e063-6394a90a91c8SPL ID 5a6e614b-9ae9-9719-e063-6394a90a91c8SPL set ID 87505f8f-2056-4e55-adf5-5b7309081d7cRxCUI 1648759UNII 927AH8112L
- Pharmacologic class
- Nitrofuran Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470518424400followed by a unit qualifier and the quantityPackage 70518-4244-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Nitrofurantoin capsules, USP (macrocrystals) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci , Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, USP (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be c…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211935
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nitrofurantoin | Nitrofurantoin 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-241 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-389 |
| Nitrofurantoin | Nitrofurantoin 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-390 |
| Nitrofurantoin | Nitrofurantoin 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-391 |
| Nitrofurantoin | Nitrofurantoin 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-390 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-389 |
| Nitrofurantoin | Nitrofurantoin 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-391 |