Prescription drug · ANDA
Fenofibrate NDC 42858-454
Fenofibrate 54 mg/1 · Tablet, Film coated · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-454-45 | 4285804544542858045445 | 90 TABLET, FILM COATED in 1 BOTTLE (42858-454-45)Marketed from Jun 1, 2017 |
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 — 54 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLCNDC labeler code 42858
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076433
- Marketing start
- Listing expires
- Identifiers
- Product ID 42858-454_fc450dc8-84cf-4aa7-8498-71f1c903a27cSPL ID fc450dc8-84cf-4aa7-8498-71f1c903a27cSPL set ID 5e7b79ab-9df0-4bbf-b7a4-a44aec203555RxCUI 349287, 351133UNII U202363UOSUPC 0342858660457, 0342858454452
- 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
N442858045445followed by a unit qualifier and the quantityPackage 42858-0454-45. 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 tablets are 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. Fenofibrate Tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) ( 1 ). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidem…
Excerpt only. Read the full label for complete information.
About NDC 42858-454
- What is NDC 42858-454?
- 42858-454 is the product NDC for Fenofibrate, Fenofibrate 54 mg/1 tablet, film coated, listed with the FDA by Rhodes Pharmaceuticals LLC. It has 1 package NDC, 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?
- Rhodes Pharmaceuticals LLC, NDC labeler code 42858. 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?
- 203 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 076433
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 160 mg/1 | Tablet, Film coatedOral | Rhodes Pharmaceuticals LLC | 42858-660 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-093 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-853 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-864 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9474 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0741 |