Prescription drug · ANDA
Fenofibrate NDC 72789-410
Fenofibrate 160 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-410-30 | 72789041030 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-410-30)Marketed from Jun 5, 2024 |
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)
- Fenofibrate
- Generic name (nonproprietary)
- fenofibrate
- Active ingredients
- Fenofibrate — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076509
- Marketing start
- Listing expires
- Identifiers
- Product ID 72789-410_5b89974a-7bcc-40e0-e063-6394a90a49e4SPL ID 5b89974a-7bcc-40e0-e063-6394a90a49e4
- 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
N472789041030followed by a unit qualifier and the quantityPackage 72789-0410-30. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 076509
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 | TabletOral | Northwind Health Company, LLC | 51655-009 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4326 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-5511 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-5522 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-5511 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-5522 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | AvPAK | 50268-313 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | AvPAK | 50268-312 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-6973 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-6974 |