Prescription drug · ANDA
Fenofibrate NDC 68788-4006
Fenofibrate 145 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4006-1 | 6878840060168788400601 | 100 TABLET in 1 BOTTLE (68788-4006-1)Marketed from Aug 8, 2025 | |
| 68788-4006-3 | 6878840060368788400603 | 30 TABLET in 1 BOTTLE (68788-4006-3)Marketed from Aug 8, 2025 | |
| 68788-4006-6 | 6878840060668788400606 | 60 TABLET in 1 BOTTLE (68788-4006-6)Marketed from Aug 8, 2025 | |
| 68788-4006-9 | 6878840060968788400609 | 90 TABLET in 1 BOTTLE (68788-4006-9)Marketed from Aug 8, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090856
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-4006_2e6711e9-782d-46bd-9447-6612fe7d0fe7SPL ID 2e6711e9-782d-46bd-9447-6612fe7d0fe7SPL set ID 2e6711e9-782d-46bd-9447-6612fe7d0fe7RxCUI 477560UNII 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
N468788400601followed by a unit qualifier and the quantityPackage 68788-4006-01. 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 is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: • To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1 ). • For treatment of adult patients with severe hypertriglyceridemia ( 1.2 ). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1 ). 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablets USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholest…
Excerpt only. Read the full label for complete information.
About NDC 68788-4006
- What is NDC 68788-4006?
- 68788-4006 is the product NDC for Fenofibrate, Fenofibrate 145 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7926 | 50090-7926-0050090-7926-01 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7927 | 50090-7927-00 |
Other NDCs under ANDA 090856
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 | TabletOral | Major Pharmaceuticals | 0904-7480 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | AvPAK | 50268-338 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | American Health Packaging | 60687-618 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | American Health Packaging | 60687-629 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-388 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-389 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-018 |