Prescription drug · ANDA
Fenofibrate NDC 60687-713
Fenofibrate 200 mg/1 · Capsule · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-713-21 | 60687071321 | 30 BLISTER PACK in 1 CARTON (60687-713-21) / 1 CAPSULE in 1 BLISTER PACK (60687-713-11)Marketed from Mar 13, 2023 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205566
- Marketing start
- Listing expires
- Identifiers
- Product ID 60687-713_55a44f6c-9341-255b-e063-6394a90a4f9dSPL ID 55a44f6c-9341-255b-e063-6394a90a4f9dSPL set ID 8b4488f4-bef6-408c-9fca-3e4aebceff9aRxCUI 310289UNII 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
N460687071321followed by a unit qualifier and the quantityPackage 60687-0713-21. 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 Treatment of Hypercholesterolemia Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205566
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 67 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-580 |
| fenofibrate | Fenofibrate 134 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6120 |
| fenofibrate | Fenofibrate 134 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-581 |
| fenofibrate | Fenofibrate 200 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-582 |