gemfibrozil

Generic: gemfibrozil

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

gemfibrozil 600 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-745
Product ID 43063-745_3ef18652-9145-bc21-e063-6394a90a74fb
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 43063745
Hyphenated Format 43063-745

Supplemental Identifiers

RxCUI
310459
UPC
0343063745601
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 ANDA077836 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-745-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (43063-745-93)
source: ndc

Packages (2)

43063-745-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-745-60) 43063-745-93 180 TABLET in 1 BOTTLE, PLASTIC (43063-745-93)

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": "3ef18652-9145-bc21-e063-6394a90a74fb", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0343063745601"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["5501438d-5247-4f2a-8e15-085276d01725"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-745-60)", "package_ndc": "43063-745-60", "marketing_start_date": "20170209"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (43063-745-93)", "package_ndc": "43063-745-93", "marketing_start_date": "20171212"}], "brand_name": "Gemfibrozil", "product_id": "43063-745_3ef18652-9145-bc21-e063-6394a90a74fb", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "43063-745", "generic_name": "Gemfibrozil", "labeler_name": "PD-Rx Pharmaceuticals, 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"}