gemfibrozil

Generic: gemfibrozil

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

Drug Facts

Product Profile

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

gemfibrozil 600 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-821
Product ID 69097-821_2d16c495-7862-4ffc-a9ee-a1c816af5ae5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077836
Listing Expiration 2026-12-31
Marketing Start 2016-10-13

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 69097821
Hyphenated Format 69097-821

Supplemental Identifiers

RxCUI
310459
UPC
0369097821036
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 ANDA077836 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (69097-821-03)
  • 100 TABLET in 1 BOTTLE (69097-821-07)
  • 500 TABLET in 1 BOTTLE (69097-821-12)
source: ndc

Packages (3)

69097-821-03 60 TABLET in 1 BOTTLE (69097-821-03) 69097-821-07 100 TABLET in 1 BOTTLE (69097-821-07) 69097-821-12 500 TABLET in 1 BOTTLE (69097-821-12)

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": "2d16c495-7862-4ffc-a9ee-a1c816af5ae5", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0369097821036"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["05bfbcdc-03ab-4fba-9582-980602410ef9"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (69097-821-03)", "package_ndc": "69097-821-03", "marketing_start_date": "20161013"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-821-07)", "package_ndc": "69097-821-07", "marketing_start_date": "20161013"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-821-12)", "package_ndc": "69097-821-12", "marketing_start_date": "20161013"}], "brand_name": "Gemfibrozil", "product_id": "69097-821_2d16c495-7862-4ffc-a9ee-a1c816af5ae5", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "69097-821", "generic_name": "Gemfibrozil", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemfibrozil", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA077836", "marketing_category": "ANDA", "marketing_start_date": "20161013", "listing_expiration_date": "20261231"}