Prescription drug · ANDA
Fenofibrate NDC 50090-3044
Fenofibrate 145 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3044-0 | 50090304400 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-3044-0)Marketed from Jun 8, 2017 |
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, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204598
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-3044_ada831fc-d14a-4b44-824f-6e6dac65b073SPL ID ada831fc-d14a-4b44-824f-6e6dac65b073SPL set ID d9c60b43-dc61-4976-b31f-09c8f8a33138RxCUI 477560, 477562UNII 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
N450090304400followed by a unit qualifier and the quantityPackage 50090-3044-00. 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)
Fenofibratetablets are indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adultswith 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 notpossible. Limitations of Use • Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7 )]. • Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized co…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204598
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 48 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3056 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-045 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8106 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2654 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2688 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-595 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-596 |