gemfibrozil

Generic: gemfibrozil

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-131
Product ID 75834-131_46c22ec0-5ec6-472c-a8cf-b89c27dc6448
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203266
Listing Expiration 2026-12-31
Marketing Start 2017-02-15

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 75834131
Hyphenated Format 75834-131

Supplemental Identifiers

RxCUI
310459
UPC
0375834131603
UNII
Q8X02027X3
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 gemfibrozil (source: ndc)
Generic Name gemfibrozil (source: ndc)
Application Number ANDA203266 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (75834-131-05)
  • 180 TABLET in 1 BOTTLE (75834-131-18)
  • 60 TABLET in 1 BOTTLE (75834-131-60)
source: ndc

Packages (3)

75834-131-05 500 TABLET in 1 BOTTLE (75834-131-05) 75834-131-18 180 TABLET in 1 BOTTLE (75834-131-18) 75834-131-60 60 TABLET in 1 BOTTLE (75834-131-60)

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": "46c22ec0-5ec6-472c-a8cf-b89c27dc6448", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0375834131603"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["a086fc16-e6f3-47fd-b577-7c611e735834"], "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": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (75834-131-05)", "package_ndc": "75834-131-05", "marketing_start_date": "20170215"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (75834-131-18)", "package_ndc": "75834-131-18", "marketing_start_date": "20170215"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (75834-131-60)", "package_ndc": "75834-131-60", "marketing_start_date": "20170215"}], "brand_name": "Gemfibrozil", "product_id": "75834-131_46c22ec0-5ec6-472c-a8cf-b89c27dc6448", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "75834-131", "generic_name": "Gemfibrozil", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemfibrozil", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA203266", "marketing_category": "ANDA", "marketing_start_date": "20170215", "listing_expiration_date": "20261231"}