What is NDC 68180-128?

68180-128 is the product NDC for Fenofibric acid, Choline fenofibrate 45 mg/1 capsule, delayed release, listed with the FDA by Lupin Pharmaceuticals, Inc..

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fenofibric acid NDC 68180-128 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-128Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0128Add the package segment from the table below.

Product information

Brand name (proprietary): Fenofibric acid
Generic name (nonproprietary): fenofibric acid
Active ingredients: Choline fenofibrate — 45 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200750
Marketing start: Dec 4, 2013
Listing expires: Dec 31, 2027
Identifiers: Product ID 68180-128_574221bf-1643-4dd4-8ac6-29f387ce5eafSPL ID 574221bf-1643-4dd4-8ac6-29f387ce5eafSPL set ID b9a3f97c-9e31-4a5f-822f-c9d45e394493RxCUI 828373, 828379UNII 4BMH7IZT98UPC 0368180128014, 0368180129011
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.

Product label

Current FDA label (SPL), effective Dec 8, 2023.

Indications (excerpt from the label)

Fenofibric acid delayed-release capsule is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: Reduce TG in patients with severe hypertriglyceridemia ( 1.1 ). Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2 ). Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsule did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1 ). 1.1 Treatment of Severe Hypertriglyceridemia Fenofibric acid delayed-release capsules are indicated as adjunctive therap…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-128

What is NDC 68180-128?: 68180-128 is the product NDC for Fenofibric acid, Choline fenofibrate 45 mg/1 capsule, delayed release, listed with the FDA by Lupin Pharmaceuticals, Inc..
What drug is associated with this NDC?: Fenofibric acid.
What is the active ingredient?: Choline fenofibrate.
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fenofibric acid NDCs
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	Choline fenofibrate 135 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-295	33342-0295-1033342-0295-56
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

All 14 Fenofibric acid NDCs

Other NDCs under ANDA 200750

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 200750
Product	Strength	Form · route	Labeler	Product NDC
Fenofibric acid	Choline fenofibrate 135 mg/1	Capsule, Delayed releaseOral	Lupin Pharmaceuticals, Inc.	68180-129