Prescription drug · ANDA
Fenofibrate NDC 0378-3066
Fenofibrate 145 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-3066-05 | 00378306605 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-05)Marketed from May 14, 2013 | |
| 0378-3066-77 | 00378306677 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-77)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 — 145 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202856
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-3066_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
N400378306605followed by a unit qualifier and the quantityPackage 00378-3066-05. 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 . Limitations of Use • Markedly elevated 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 reduce coronary heart disease morbidity and mortality in two large, rando…
Excerpt only. Read the full label for complete information.
About NDC 0378-3066
- What is NDC 0378-3066?
- 0378-3066 is the product NDC for Fenofibrate, Fenofibrate 145 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 145 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-040 | 48433-0040-20 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-039 | 48433-0039-20 |
| 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 145 mg/1 | TabletOral | AvKARE | 73190-016 | 73190-0016-90 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | AvKARE | 73190-015 | 73190-0015-90 |
| 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 202856
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 | Mylan Institutional Inc. | 51079-599 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-608 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-3065 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7242 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-040 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-039 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2016 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6934 |