gemfibrozil

Generic: gemfibrozil

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-784
Product ID 16571-784_3e8381a4-86bf-4b7b-8631-ba616a85f3ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202726
Listing Expiration 2026-12-31
Marketing Start 2015-09-16

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 16571784
Hyphenated Format 16571-784

Supplemental Identifiers

RxCUI
310459
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 ANDA202726 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (16571-784-06)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-784-50)
source: ndc

Packages (2)

16571-784-06 60 TABLET, FILM COATED in 1 BOTTLE (16571-784-06) 16571-784-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-784-50)

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": "3e8381a4-86bf-4b7b-8631-ba616a85f3ed", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["8f36abfa-dc52-4c99-8a4a-b0cb80c3249a"], "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": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (16571-784-06)", "package_ndc": "16571-784-06", "marketing_start_date": "20150916"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-784-50)", "package_ndc": "16571-784-50", "marketing_start_date": "20150916"}], "brand_name": "Gemfibrozil", "product_id": "16571-784_3e8381a4-86bf-4b7b-8631-ba616a85f3ed", "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": "16571-784", "generic_name": "Gemfibrozil", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemfibrozil", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA202726", "marketing_category": "ANDA", "marketing_start_date": "20150916", "listing_expiration_date": "20261231"}