gemfibrozil

Generic: gemfibrozil

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
Northstar RxLLC

Identifiers & Regulatory

Product NDC 16714-101
Product ID 16714-101_2c6af761-6987-4e2e-a184-7ac55efd36c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079072
Marketing Start 2010-12-20
Marketing End 2026-06-30

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 16714101
Hyphenated Format 16714-101

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 ANDA079072 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (16714-101-02)
  • 500 TABLET in 1 BOTTLE (16714-101-05)
source: ndc

Packages (2)

16714-101-02 60 TABLET in 1 BOTTLE (16714-101-02) 16714-101-05 500 TABLET in 1 BOTTLE (16714-101-05)

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": "2c6af761-6987-4e2e-a184-7ac55efd36c3", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["75cac02c-56e3-4dfe-b1e2-4ce166b28833"], "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": ["Northstar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (16714-101-02)", "package_ndc": "16714-101-02", "marketing_end_date": "20260630", "marketing_start_date": "20101220"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16714-101-05)", "package_ndc": "16714-101-05", "marketing_end_date": "20260630", "marketing_start_date": "20101220"}], "brand_name": "Gemfibrozil", "product_id": "16714-101_2c6af761-6987-4e2e-a184-7ac55efd36c3", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "16714-101", "generic_name": "gemfibrozil", "labeler_name": "Northstar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemfibrozil", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA079072", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20101220"}