fenofibric acid

Generic: fenofibric acid

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fenofibric acid 135 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-348
Product ID 42571-348_38613bf4-bb82-1834-e063-6294a90ab048
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213450
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

Pharmacologic Class

Established (EPC)
peroxisome proliferator receptor alpha agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571348
Hyphenated Format 42571-348

Supplemental Identifiers

RxCUI
828373 828379
UPC
0342571347901 0342571348908
UNII
BGF9MN2HU1
NUI
N0000175596

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 ANDA213450 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 135 mg/1
source: ndc
Packaging
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-05)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-30)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-90)
source: ndc

Packages (3)

42571-348-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-05) 42571-348-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-30) 42571-348-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-90)

Ingredients (1)

fenofibric acid (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": "38613bf4-bb82-1834-e063-6294a90ab048", "openfda": {"nui": ["N0000175596"], "upc": ["0342571347901", "0342571348908"], "unii": ["BGF9MN2HU1"], "rxcui": ["828373", "828379"], "spl_set_id": ["9c87ff52-04d5-4833-8cec-c33bb646b7c7"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-05)", "package_ndc": "42571-348-05", "marketing_start_date": "20200901"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-30)", "package_ndc": "42571-348-30", "marketing_start_date": "20200901"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-90)", "package_ndc": "42571-348-90", "marketing_start_date": "20200901"}], "brand_name": "Fenofibric acid", "product_id": "42571-348_38613bf4-bb82-1834-e063-6294a90ab048", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "42571-348", "generic_name": "Fenofibric acid", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibric acid", "active_ingredients": [{"name": "FENOFIBRIC ACID", "strength": "135 mg/1"}], "application_number": "ANDA213450", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}