Prescription drug · ANDA
Nitrofurantion NDC 57664-231
Nitrofurantoin 25 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-231-18 | 57664023118 | 1000 CAPSULE in 1 BOTTLE (57664-231-18)Marketed from Apr 15, 2016 | |
| 57664-231-88 | 57664023188 | 100 CAPSULE in 1 BOTTLE (57664-231-88)Marketed from Apr 15, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Nitrofurantion
- Generic name (nonproprietary)
- nitrofurantion
- Active ingredients
- Nitrofurantoin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201722
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 57664-231_4ed13848-1151-c63a-e063-6394a90a3a05SPL ID 4ed13848-1151-c63a-e063-6394a90a3a05SPL set ID 05f25774-f56a-48ef-bac3-8af663f8581aRxCUI 311994, 311995, 1648759UNII 927AH8112LUPC 0357664232187, 0357664233184, 0357664231180
- 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
N457664023118followed by a unit qualifier and the quantityPackage 57664-0231-18. 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 ca…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201722
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 |
|---|---|---|---|---|
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | BluePoint Labortories | 68001-386 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2363 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0024 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-171 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5693 |
| Nitrofurantion | Nitrofurantoin 50 mg/1 | CapsuleOral | BluePoint Labortories | 68001-385 |
| Nitrofurantion | Nitrofurantoin 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-232 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-233 |
| Nitrofurantion | Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Labortories | 68001-384 |