gemfibrozil

Generic: gemfibrozil

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-160
Product ID 62135-160_2589e155-f097-67fc-e063-6294a90a20b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074270
Listing Expiration 2026-12-31
Marketing Start 1993-09-27

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 62135160
Hyphenated Format 62135-160

Supplemental Identifiers

RxCUI
310459
UPC
0362135160609 0362135160319
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 ANDA074270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 300 TABLET, FILM COATED in 1 BOTTLE (62135-160-31)
  • 60 TABLET, FILM COATED in 1 BOTTLE (62135-160-60)
source: ndc

Packages (2)

62135-160-31 300 TABLET, FILM COATED in 1 BOTTLE (62135-160-31) 62135-160-60 60 TABLET, FILM COATED in 1 BOTTLE (62135-160-60)

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": "2589e155-f097-67fc-e063-6294a90a20b8", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0362135160609", "0362135160319"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["b8bb442e-66dc-435e-830c-4ba3daa47c04"], "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": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET, FILM COATED in 1 BOTTLE (62135-160-31)", "package_ndc": "62135-160-31", "marketing_start_date": "20230825"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (62135-160-60)", "package_ndc": "62135-160-60", "marketing_start_date": "20230825"}], "brand_name": "Gemfibrozil", "product_id": "62135-160_2589e155-f097-67fc-e063-6294a90a20b8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "62135-160", "generic_name": "Gemfibrozil", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemfibrozil", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA074270", "marketing_category": "ANDA", "marketing_start_date": "19930927", "listing_expiration_date": "20261231"}