fenofibric acid

Generic: fenofibric acid

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

Drug Facts

Product Profile

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

fenofibric acid 135 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-245
Product ID 46708-245_4f5277a1-2983-4cf9-b589-714d5fc586c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208705
Listing Expiration 2026-12-31
Marketing Start 2017-05-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708245
Hyphenated Format 46708-245

Supplemental Identifiers

RxCUI
828373 828379
UPC
0346708244309 0346708245306
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 ANDA208705 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 135 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-90)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-91)
source: ndc

Packages (3)

46708-245-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30) 46708-245-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-90) 46708-245-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-91)

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": "4f5277a1-2983-4cf9-b589-714d5fc586c0", "openfda": {"nui": ["N0000175596"], "upc": ["0346708244309", "0346708245306"], "unii": ["BGF9MN2HU1"], "rxcui": ["828373", "828379"], "spl_set_id": ["c880d43a-fa8c-4f7a-a488-419bae7cc311"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30)", "package_ndc": "46708-245-30", "marketing_start_date": "20170518"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-90)", "package_ndc": "46708-245-90", "marketing_start_date": "20170518"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-91)", "package_ndc": "46708-245-91", "marketing_start_date": "20170518"}], "brand_name": "Fenofibric Acid", "product_id": "46708-245_4f5277a1-2983-4cf9-b589-714d5fc586c0", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "46708-245", "generic_name": "Fenofibric Acid", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibric Acid", "active_ingredients": [{"name": "FENOFIBRIC ACID", "strength": "135 mg/1"}], "application_number": "ANDA208705", "marketing_category": "ANDA", "marketing_start_date": "20170518", "listing_expiration_date": "20261231"}