Prescription drug · ANDA
Fenofibrate NDC 62332-361
Fenofibrate 145 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-361-30 | 62332036130 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-361-30)Marketed from Aug 9, 2019 | |
| 62332-361-71 | 62332036171 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-361-71)Marketed from Aug 9, 2019 | |
| 62332-361-90 | 62332036190 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-361-90)Marketed from Aug 9, 2019 |
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 — 145 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210476
- Marketing start
- Listing expires
- Identifiers
- Product ID 62332-361_69d8eb8b-074c-4209-8bbd-ac35b1364d15SPL ID 69d8eb8b-074c-4209-8bbd-ac35b1364d15SPL set ID 5c579378-e00e-4802-b9d3-c062cf8bd9f4RxCUI 477560, 477562UNII U202363UOSUPC 0362332360307, 0362332361304
- 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
N462332036130followed by a unit qualifier and the quantityPackage 62332-0361-30. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Fenofibrate tablet is indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use • Markedly elevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)] . • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210476
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 145 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-361 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-360 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-360 |