Prescription drug · ANDA
fenofibrate NDC 71335-1286
Fenofibrate 160 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1286-1 | 71335128601 | 30 TABLET in 1 BOTTLE (71335-1286-1)Marketed from Sep 3, 2019 | |
| 71335-1286-2 | 71335128602 | 90 TABLET in 1 BOTTLE (71335-1286-2)Marketed from Aug 28, 2019 | |
| 71335-1286-3 | 71335128603 | 60 TABLET in 1 BOTTLE (71335-1286-3)Marketed from Dec 28, 2021 | |
| 71335-1286-4 | 71335128604 | 28 TABLET in 1 BOTTLE (71335-1286-4)Marketed from Dec 28, 2021 | |
| 71335-1286-5 | 71335128605 | 100 TABLET in 1 BOTTLE (71335-1286-5)Marketed from Dec 28, 2021 |
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 — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210138
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1286_34f5820c-765f-4425-a575-5adb5633b3ceSPL ID 34f5820c-765f-4425-a575-5adb5633b3ceSPL set ID 42b1ad55-c449-4250-a666-bb36a6ff5b53RxCUI 349287UNII 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
N471335128601followed by a unit qualifier and the quantityPackage 71335-1286-01. 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, USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholestero…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210138
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 | Ajanta Pharma USA Inc. | 27241-117 |
| fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-116 |
| fenofibrate | Fenofibrate 160 mg/1 | TabletOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8270 |
| fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Proficient Rx LP | 71205-190 |
| fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Quality Care Products, LLC | 55700-876 |
| fenofibrate | Fenofibrate 160 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4991 |
| fenofibrate | Fenofibrate 54 mg/1 | TabletOral | A-S Medication Solutions | 50090-5244 |