Prescription drug · ANDA
Fenofibrate NDC 62332-539
Fenofibrate 160 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-539-90 | 62332053990 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-539-90)Marketed from Feb 12, 2019 | |
| 62332-539-91 | 62332053991 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-539-91)Marketed from Feb 12, 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 — 160 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 209660
- Marketing start
- Listing expires
- Identifiers
- Product ID 62332-539_ee0b43e8-d8dd-4a74-aac2-ee828d85b364SPL ID ee0b43e8-d8dd-4a74-aac2-ee828d85b364SPL set ID 4387adac-eea0-40c5-8111-1b70e0d98d7eRxCUI 349287, 351133UNII U202363UOSUPC 0362332538904, 0362332539901
- 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
N462332053990followed by a unit qualifier and the quantityPackage 62332-0539-90. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 209660
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 54 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-554 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-555 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-554 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-555 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-837 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-838 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-538 |