Prescription drug · ANDA
Fenofibrate NDC 70518-4721
Fenofibrate 54 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4721-0 | 70518472100 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4721-0)Marketed from Aug 4, 2026 |
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)
- Fenofibrate
- Generic name (nonproprietary)
- fenofibrate
- Active ingredients
- Fenofibrate — 54 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216798
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4721_583eb9d0-fc65-53e8-e063-6294a90ae0fcSPL ID 583eb9d0-fc65-53e8-e063-6294a90ae0fcSPL set ID b6b5d74d-d418-4ada-8ccd-592b0f57b2ffRxCUI 351133UNII U202363UOS
- Pharmacologic class
- Peroxisome Proliferator Receptor alpha Agonist
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
N470518472100followed by a unit qualifier and the quantityPackage 70518-4721-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 216798
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 |
|---|---|---|---|---|
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8861 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7208 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7209 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-575 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-576 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3542 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7572 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3086 |