Prescription drug · ANDA
Fenofibrate NDC 0378-3065
Fenofibrate 48 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-3065-77 | 00378306577 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3065-77)Marketed from May 14, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 48 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202856
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-3065_5683e52e-e8f1-47ab-a77b-ade2abe12c07SPL ID 5683e52e-e8f1-47ab-a77b-ade2abe12c07SPL set ID 0f958942-1504-40a1-8ad8-43df2c3f717eRxCUI 477560, 477562UNII U202363UOSUPC 0303783066776, 0303783065779
- 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
N400378306577followed by a unit qualifier and the quantityPackage 00378-3065-77. 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.