gemfibrozil

Generic: gemfibrozil

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-601
Product ID 71610-601_8cfd64d4-38e2-4c2c-97b0-9284da5fe6da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214603
Listing Expiration 2026-12-31
Marketing Start 2021-01-20

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 71610601
Hyphenated Format 71610-601

Supplemental Identifiers

RxCUI
310459
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 ANDA214603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71610-601-53)
  • 90 TABLET in 1 BOTTLE (71610-601-60)
source: ndc

Packages (2)

71610-601-53 60 TABLET in 1 BOTTLE (71610-601-53) 71610-601-60 90 TABLET in 1 BOTTLE (71610-601-60)

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": "8cfd64d4-38e2-4c2c-97b0-9284da5fe6da", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["7379a1c1-d34f-4eb8-acb8-c5cbaea0f017"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-601-53)", "package_ndc": "71610-601-53", "marketing_start_date": "20211019"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-601-60)", "package_ndc": "71610-601-60", "marketing_start_date": "20211006"}], "brand_name": "GEMFIBROZIL", "product_id": "71610-601_8cfd64d4-38e2-4c2c-97b0-9284da5fe6da", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "71610-601", "generic_name": "Gemfibrozil", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMFIBROZIL", "active_ingredients": [{"name": "GEMFIBROZIL", "strength": "600 mg/1"}], "application_number": "ANDA214603", "marketing_category": "ANDA", "marketing_start_date": "20210120", "listing_expiration_date": "20261231"}