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 | 4670800843046708008430 | 30 CAPSULE in 1 BOTTLE (46708-084-30)Marketed from Oct 22, 2020 | |
| 46708-084-31 | 4670800843146708008431 | 100 CAPSULE in 1 BOTTLE (46708-084-31)Marketed from Oct 22, 2020 | |
| 46708-084-71 | 4670800847146708008471 | 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
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & 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 hy…
Excerpt only. Read the full label for complete information.
About NDC 46708-084
- What is NDC 46708-084?
- 46708-084 is the product NDC for Fenofibrate, Fenofibrate 67 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fenofibrate.
- What is the active ingredient?
- Fenofibrate.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fenofibrate?
- 201 other product NDCs are listed under this name. See all Fenofibrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fenofibrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4721 | 70518-4721-00 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4672 | 70518-4672-00 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-039 | 48433-0039-20 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-040 | 48433-0040-20 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-347 | 33342-0347-1033342-0347-1233342-0347-47 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-348 | 33342-0348-1033342-0348-1233342-0348-15 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | AvKARE | 73190-015 | 73190-0015-90 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | AvKARE | 73190-016 | 73190-0016-90 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | NorthStar RxLLC | 72603-840 | 72603-0840-01 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | NorthStar RxLLC | 72603-841 | 72603-0841-0172603-0841-02 |
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 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 | A-S Medication Solutions | 50090-7994 |
| Fenofibrate | Fenofibrate 134 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-8096 |
| Fenofibrate | Fenofibrate 67 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-084 |
| Fenofibrate | Fenofibrate 134 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-085 |
| Fenofibrate | Fenofibrate 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-086 |