gemfibrozil

Generic: gemfibrozil

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4305
Product ID 70518-4305_402d85bd-9a53-95e2-e063-6394a90a1473
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214603
Listing Expiration 2026-12-31
Marketing Start 2025-03-09

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 705184305
Hyphenated Format 70518-4305

Supplemental Identifiers

RxCUI
310459
UNII
Q8X02027X3
NUI
N0000175596 N0000175375 M0543661

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 gemfibrozil (source: ndc)
Generic Name gemfibrozil (source: ndc)
Application Number ANDA214603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE, PLASTIC (70518-4305-0)
source: ndc

Packages (1)

70518-4305-0 180 TABLET in 1 BOTTLE, PLASTIC (70518-4305-0)

Ingredients (1)

gemfibrozil (600 mg/1)

Linked Drug Pages (1)

GEMFIBROZIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "402d85bd-9a53-95e2-e063-6394a90a1473", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["42e40524-57e9-4fee-993f-be0fda14936b"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (70518-4305-0)", "package_ndc": "70518-4305-0", "marketing_start_date": "20250309"}], "brand_name": "GEMFIBROZIL", "product_id": "70518-4305_402d85bd-9a53-95e2-e063-6394a90a1473", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "70518-4305", "generic_name": "Gemfibrozil", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMFIBROZIL", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA214603", "marketing_category": "ANDA", "marketing_start_date": "20250309", "listing_expiration_date": "20261231"}