gemfibrozil

Generic: gemfibrozil

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-553
Product ID 68382-553_9c4294b2-eee2-42d7-b260-6fc2e7e28833
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204189
Listing Expiration 2026-12-31
Marketing Start 2019-01-15

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 68382553
Hyphenated Format 68382-553

Supplemental Identifiers

RxCUI
310459
UPC
0368382553065
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 ANDA204189 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-553-01)
  • 500 TABLET in 1 BOTTLE (68382-553-05)
  • 30 TABLET in 1 BOTTLE (68382-553-06)
  • 1000 TABLET in 1 BOTTLE (68382-553-10)
  • 60 TABLET in 1 BOTTLE (68382-553-14)
  • 90 TABLET in 1 BOTTLE (68382-553-16)
  • 10 BLISTER PACK in 1 CARTON (68382-553-30) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (7)

68382-553-01 100 TABLET in 1 BOTTLE (68382-553-01) 68382-553-05 500 TABLET in 1 BOTTLE (68382-553-05) 68382-553-06 30 TABLET in 1 BOTTLE (68382-553-06) 68382-553-10 1000 TABLET in 1 BOTTLE (68382-553-10) 68382-553-14 60 TABLET in 1 BOTTLE (68382-553-14) 68382-553-16 90 TABLET in 1 BOTTLE (68382-553-16) 68382-553-30 10 BLISTER PACK in 1 CARTON (68382-553-30) / 10 TABLET in 1 BLISTER PACK

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": "9c4294b2-eee2-42d7-b260-6fc2e7e28833", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0368382553065"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["556945e8-4100-4538-bcba-af5b2f13a7e8"], "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": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-553-01)", "package_ndc": "68382-553-01", "marketing_start_date": "20190115"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-553-05)", "package_ndc": "68382-553-05", "marketing_start_date": "20190115"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-553-06)", "package_ndc": "68382-553-06", "marketing_start_date": "20190115"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-553-10)", "package_ndc": "68382-553-10", "marketing_start_date": "20190115"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68382-553-14)", "package_ndc": "68382-553-14", "marketing_start_date": "20190115"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-553-16)", "package_ndc": "68382-553-16", "marketing_start_date": "20190115"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-553-30)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68382-553-30", "marketing_start_date": "20190115"}], "brand_name": "Gemfibrozil", "product_id": "68382-553_9c4294b2-eee2-42d7-b260-6fc2e7e28833", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "68382-553", "generic_name": "Gemfibrozil", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemfibrozil", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA204189", "marketing_category": "ANDA", "marketing_start_date": "20190115", "listing_expiration_date": "20261231"}