Prescription drug · ANDA
Fenofibric acid NDC 33342-295
Choline fenofibrate 135 mg/1 · Capsule, Delayed release · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-295-10 | 3334202951033342029510 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-295-10)Marketed from Feb 26, 2024 | |
| 33342-295-56 | 3334202955633342029556 | 10 BLISTER PACK in 1 CARTON (33342-295-56) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 26, 2024 |
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)
- Fenofibric acid
- Generic name (nonproprietary)
- fenofibric acid
- Active ingredients
- Choline fenofibrate — 135 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207796
- Marketing start
- Listing expires
- Identifiers
- Product ID 33342-295_94a44831-98b3-41d4-89da-89a43b25d15fSPL ID 94a44831-98b3-41d4-89da-89a43b25d15fSPL set ID af225492-73b0-49bb-b32f-5399c3c3ec6dRxCUI 828373, 828379UNII 4BMH7IZT98UPC 0333342295101, 0333342294104
- 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
N433342029510followed by a unit qualifier and the quantityPackage 33342-0295-10. 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)
Fenofibric acid delayed-release capsules 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. 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 i…
Excerpt only. Read the full label for complete information.
About NDC 33342-295
- What is NDC 33342-295?
- 33342-295 is the product NDC for Fenofibric acid, Choline fenofibrate 135 mg/1 capsule, delayed release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fenofibric acid.
- What is the active ingredient?
- Choline fenofibrate.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fenofibric acid?
- 13 other product NDCs are listed under this name. See all Fenofibric acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fenofibric acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1324 | 00115-1324-10 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1325 | 00115-1325-10 |
| Fenofibric acid | Choline fenofibrate 45 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-294 | 33342-0294-1033342-0294-12 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-216 | 59651-0216-90 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-217 | 59651-0217-90 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Leading Pharma, LLC | 69315-281 | 69315-0281-09 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Leading Pharma, LLC | 69315-282 | 69315-0282-09 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-245 | 46708-0245-3046708-0245-9046708-0245-91 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-244 | 46708-0244-3046708-0244-9046708-0244-91 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-244 | 62332-0244-3062332-0244-9062332-0244-91 |
Other NDCs under ANDA 207796
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 |
|---|---|---|---|---|
| Fenofibric acid | Choline fenofibrate 45 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-294 |