fenofibric acid delayed-release

Generic: fenofibric acid

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

Drug Facts

Product Profile

Brand Name fenofibric acid delayed-release
Generic Name fenofibric acid
Labeler laurus labs limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

fenofibric acid 135 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-945
Product ID 42385-945_f0e00f9f-65f5-407a-e053-2a95a90a260f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211626
Listing Expiration 2026-12-31
Marketing Start 2020-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385945
Hyphenated Format 42385-945

Supplemental Identifiers

RxCUI
828373 828379
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 delayed-release (source: ndc)
Generic Name fenofibric acid (source: ndc)
Application Number ANDA211626 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 135 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-11)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-30)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-90)
source: ndc

Packages (3)

42385-945-11 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-11) 42385-945-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-30) 42385-945-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-90)

Ingredients (1)

fenofibric acid (135 mg/1)

Linked Drug Pages (1)

FENOFIBRIC ACID DELAYED-RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f0e00f9f-65f5-407a-e053-2a95a90a260f", "openfda": {"nui": ["N0000175596"], "unii": ["BGF9MN2HU1"], "rxcui": ["828373", "828379"], "spl_set_id": ["302ffbf8-448e-4729-949f-40d457e30ab4"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-11)", "package_ndc": "42385-945-11", "marketing_start_date": "20200824"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-30)", "package_ndc": "42385-945-30", "marketing_start_date": "20200824"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-90)", "package_ndc": "42385-945-90", "marketing_start_date": "20200824"}], "brand_name": "FENOFIBRIC ACID DELAYED-RELEASE", "product_id": "42385-945_f0e00f9f-65f5-407a-e053-2a95a90a260f", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "42385-945", "generic_name": "Fenofibric Acid", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRIC ACID DELAYED-RELEASE", "active_ingredients": [{"name": "FENOFIBRIC ACID", "strength": "135 mg/1"}], "application_number": "ANDA211626", "marketing_category": "ANDA", "marketing_start_date": "20200824", "listing_expiration_date": "20261231"}