Prescription drug · ANDA
Fenofibrate NDC 0904-7161
Fenofibrate 145 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7161-61 | 0090471616100904716161 | 100 BLISTER PACK in 1 CARTON (0904-7161-61) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 15, 2016 |
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
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208709
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7161_fd80c625-958e-4895-bdfa-aad99dae8941SPL ID fd80c625-958e-4895-bdfa-aad99dae8941SPL set ID bbffd586-f63a-4a84-bdfb-3e4a1df6449eRxCUI 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
N400904716161followed by a unit qualifier and the quantityPackage 00904-7161-61. 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, randomize…
Excerpt only. Read the full label for complete information.
About NDC 0904-7161
- What is NDC 0904-7161?
- 0904-7161 is the product NDC for Fenofibrate, Fenofibrate 145 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 208709
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8530 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | A-S Medication Solutions | 50090-4031 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | A-S Medication Solutions | 50090-5327 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-234 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-866 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5101 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Cipla USA Inc. | 69097-458 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | Cipla USA Inc. | 69097-459 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0891 |