fenofibric acid

Generic: fenofibric acid

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibric acid
Generic Name fenofibric acid
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

choline fenofibrate 135 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-129
Product ID 68180-129_574221bf-1643-4dd4-8ac6-29f387ce5eaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200750
Listing Expiration 2026-12-31
Marketing Start 2013-12-04

Pharmacologic Class

Classes
peroxisome proliferator receptor alpha agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180129
Hyphenated Format 68180-129

Supplemental Identifiers

RxCUI
828373 828379
UPC
0368180128014 0368180129011
UNII
4BMH7IZT98

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fenofibric acid (source: ndc)
Generic Name fenofibric acid (source: ndc)
Application Number ANDA200750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 135 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Fenofibric acid delayed-release capsules are supplied in two dose strengths as follows: Fenofibric acid delayed-release capsules, 45 mg are size '3' capsule with brown cap and yellow body, imprinted with "LU" on cap and "Q41" on body in black ink, containing four white to off white mini-tablets. The delayed-release capsules are available in bottles of 90's (NDC 68180-128-09); 100's (NDC 68180-128-01) and 500's (NDC 68180-128-02). Fenofibric acid delayed-release capsules, 135 mg are size '0' capsule with blue opaque cap and yellow opaque body, imprinted with "LU" on cap and "Q42" on body in black ink, containing twelve white to off white mini-tablets. The delayed-release capsules are available in bottle of 90's (NDC 68180-129-09); 100's (NDC 68180-129-01) and 500's (NDC 68180-129-02). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL FENOFIBRIC ACID DELAYED-RELEASE CAPSULES Rx Only 45 mg NDC 68180-128-01 100 Tablets FENOFIBRIC ACID DELAYED-RELEASE CAPSULES Rx Only 135 mg NDC 68180-129-01 100 Tablets Fenofibric Acid Delayed-Release Capsules, 45 mg-100s Fenofibric Acid Delayed-Release Capsules, 135 mg-100s
source: label

Packages (0)

No package records.

Ingredients (1)

choline fenofibrate (135 mg/1)

Linked Drug Pages (1)

Fenofibric acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "574221bf-1643-4dd4-8ac6-29f387ce5eaf", "openfda": {"upc": ["0368180128014", "0368180129011"], "unii": ["4BMH7IZT98"], "rxcui": ["828373", "828379"], "spl_set_id": ["b9a3f97c-9e31-4a5f-822f-c9d45e394493"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Fenofibric acid", "product_id": "68180-129_574221bf-1643-4dd4-8ac6-29f387ce5eaf", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68180-129", "generic_name": "Fenofibric acid", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibric acid", "active_ingredients": [{"name": "CHOLINE FENOFIBRATE", "strength": "135 mg/1"}], "application_number": "ANDA200750", "marketing_category": "ANDA", "marketing_start_date": "20131204", "listing_expiration_date": "20261231"}