Prescription drug · ANDA
Fenofibrate NDC 46708-084
Fenofibrate 67 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-084-30 | 46708008430 | 30 CAPSULE in 1 BOTTLE (46708-084-30)Marketed from Oct 22, 2020 | |
| 46708-084-31 | 46708008431 | 100 CAPSULE in 1 BOTTLE (46708-084-31)Marketed from Oct 22, 2020 | |
| 46708-084-71 | 46708008471 | 500 CAPSULE in 1 BOTTLE (46708-084-71)Marketed from Oct 22, 2020 |
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 — 67 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213842
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-084_2e637d10-c15a-48f8-9261-13b3df419c85SPL ID 2e637d10-c15a-48f8-9261-13b3df419c85SPL set ID 954753e7-c8d4-487c-b2ad-f90dfb758a92RxCUI 200311, 310288, 310289UNII U202363UOSUPC 0346708085308, 0346708086305, 0346708084301
- 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
N446708008430followed by a unit qualifier and the quantityPackage 46708-0084-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 213842
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 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7994 |
| Fenofibrate | Fenofibrate 134 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-085 |
| Fenofibrate | Fenofibrate 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-086 |
| Fenofibrate | Fenofibrate 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-086 |
| Fenofibrate | Fenofibrate 67 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-084 |
| Fenofibrate | Fenofibrate 134 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-085 |