Prescription drug · NDA
Lipofen (Fenofibrate) NDC 62559-305
Fenofibrate 50 mg/1 · Capsule · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-305-90 | 6255903059062559030590 | 90 CAPSULE in 1 BOTTLE (62559-305-90)Marketed from Sep 24, 2021 |
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)
- Lipofen
- Generic name (nonproprietary)
- fenofibrate
- Active ingredients
- Fenofibrate — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021612
- Marketing start
- Listing expires
- Identifiers
- Product ID 62559-305_1ce0749b-5c72-4b51-a0d4-df5afe06d9d6SPL ID 1ce0749b-5c72-4b51-a0d4-df5afe06d9d6SPL set ID 78b789b9-854f-46b9-97f3-a48759a6ff89RxCUI 616852, 616853, 702055, 702169UNII U202363UOSUPC 0362559306904, 0362559305907
- 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
N462559030590followed by a unit qualifier and the quantityPackage 62559-0305-90. 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)
LIPOFEN is 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. LIPOFEN is 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 hyperlipidemia when use of recommended LDL-…
Excerpt only. Read the full label for complete information.
About NDC 62559-305
- What is NDC 62559-305?
- 62559-305 is the product NDC for Lipofen (fenofibrate), Fenofibrate 50 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lipofen (Fenofibrate).
- What is the active ingredient?
- Fenofibrate.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lipofen?
- 1 other product NDC are listed under this name. See all Lipofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lipofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lipofenfenofibrate | Fenofibrate 150 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-306 | 62559-0306-90 |
Other NDCs under NDA 021612
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 50 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-460 |
| Fenofibrate | Fenofibrate 150 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-461 |
| Lipofenfenofibrate | Fenofibrate 150 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-306 |