fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-555
Product ID 46708-555_037d6074-3c99-4fdc-99f0-f0b58bdbb874
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209660
Listing Expiration 2026-12-31
Marketing Start 2019-08-01

Pharmacologic Class

Established (EPC)
peroxisome proliferator receptor alpha agonist [epc]
Mechanism of Action
peroxisome proliferator-activated receptor alpha agonists [moa]
Chemical Structure
fibric acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708555
Hyphenated Format 46708-555

Supplemental Identifiers

RxCUI
349287 351133
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

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 fenofibrate (source: ndc)
Generic Name fenofibrate (source: ndc)
Application Number ANDA209660 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-555-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-555-91)
source: ndc

Packages (2)

46708-555-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-555-90) 46708-555-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-555-91)

Ingredients (1)

fenofibrate (160 mg/1)

Linked Drug Pages (1)

Fenofibrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "037d6074-3c99-4fdc-99f0-f0b58bdbb874", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["39e61e9d-dda8-4989-a3dd-79545a5c9157"], "pharm_class_cs": ["Fibric Acids [CS]"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "pharm_class_moa": ["Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-555-90)", "package_ndc": "46708-555-90", "marketing_start_date": "20190801"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-555-91)", "package_ndc": "46708-555-91", "marketing_start_date": "20190801"}], "brand_name": "Fenofibrate", "product_id": "46708-555_037d6074-3c99-4fdc-99f0-f0b58bdbb874", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "46708-555", "generic_name": "Fenofibrate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA209660", "marketing_category": "ANDA", "marketing_start_date": "20190801", "listing_expiration_date": "20261231"}