fenofibric acid

Generic: fenofibric acid

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibric acid
Generic Name fenofibric acid
Labeler macleods pharmaceuticals limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

choline fenofibrate 45 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-294
Product ID 33342-294_94a44831-98b3-41d4-89da-89a43b25d15f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207796
Listing Expiration 2026-12-31
Marketing Start 2024-02-26

Pharmacologic Class

Classes
peroxisome proliferator receptor alpha agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342294
Hyphenated Format 33342-294

Supplemental Identifiers

RxCUI
828373 828379
UPC
0333342295101 0333342294104
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 ANDA207796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-294-10)
  • 10 BLISTER PACK in 1 CARTON (33342-294-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

33342-294-10 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-294-10) 33342-294-12 10 BLISTER PACK in 1 CARTON (33342-294-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

choline fenofibrate (45 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": "94a44831-98b3-41d4-89da-89a43b25d15f", "openfda": {"upc": ["0333342295101", "0333342294104"], "unii": ["4BMH7IZT98"], "rxcui": ["828373", "828379"], "spl_set_id": ["af225492-73b0-49bb-b32f-5399c3c3ec6d"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-294-10)", "package_ndc": "33342-294-10", "marketing_start_date": "20240226"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-294-12)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-294-12", "marketing_start_date": "20240226"}], "brand_name": "Fenofibric acid", "product_id": "33342-294_94a44831-98b3-41d4-89da-89a43b25d15f", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "33342-294", "generic_name": "Fenofibric acid", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibric acid", "active_ingredients": [{"name": "CHOLINE FENOFIBRATE", "strength": "45 mg/1"}], "application_number": "ANDA207796", "marketing_category": "ANDA", "marketing_start_date": "20240226", "listing_expiration_date": "20261231"}