Prescription drug · ANDA
Fenofibrate NDC 59651-576
Fenofibrate 160 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-576-90 | 5965105769059651057690 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-576-90)Marketed from Sep 27, 2022 |
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, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216798
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-576_728e5bad-086b-492f-9ecc-ad9562e5e25eSPL ID 728e5bad-086b-492f-9ecc-ad9562e5e25eSPL set ID a7cfa38f-b4db-40d3-8821-3f7c85e2727eRxCUI 349287, 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
N459651057690followed by a unit qualifier and the quantityPackage 59651-0576-90. 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)
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1 ). For treatment of adult patients with severe hypertriglyceridemia ( 1.2 ). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1 ). 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (To…
Excerpt only. Read the full label for complete information.
About NDC 59651-576
- What is NDC 59651-576?
- 59651-576 is the product NDC for Fenofibrate, Fenofibrate 160 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fenofibrate.
- What is the active ingredient?
- Fenofibrate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fenofibrate?
- 201 other product NDCs are listed under this name. See all Fenofibrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fenofibrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4721 | 70518-4721-00 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4672 | 70518-4672-00 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-039 | 48433-0039-20 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-040 | 48433-0040-20 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-347 | 33342-0347-1033342-0347-1233342-0347-47 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-348 | 33342-0348-1033342-0348-1233342-0348-15 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | AvKARE | 73190-015 | 73190-0015-90 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | AvKARE | 73190-016 | 73190-0016-90 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7926 | 50090-7926-0050090-7926-01 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7927 | 50090-7927-00 |
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 | 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 | A-S Medication Solutions | 50090-7572 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-575 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3542 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8861 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4721 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3086 |