gemfibrozil

Generic: gemfibrozil

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemfibrozil
Generic Name gemfibrozil
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gemfibrozil 600 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5808
Product ID 50090-5808_b54f187d-2cb7-4fb7-9fae-2fc9e812667a
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 500905808
Hyphenated Format 50090-5808

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 (50090-5808-0)
  • 90 TABLET in 1 BOTTLE (50090-5808-2)
  • 30 TABLET in 1 BOTTLE (50090-5808-3)
  • 180 TABLET in 1 BOTTLE (50090-5808-4)
source: ndc

Packages (4)

50090-5808-0 60 TABLET in 1 BOTTLE (50090-5808-0) 50090-5808-2 90 TABLET in 1 BOTTLE (50090-5808-2) 50090-5808-3 30 TABLET in 1 BOTTLE (50090-5808-3) 50090-5808-4 180 TABLET in 1 BOTTLE (50090-5808-4)

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": "b54f187d-2cb7-4fb7-9fae-2fc9e812667a", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["Q8X02027X3"], "rxcui": ["310459"], "spl_set_id": ["1967afce-ce55-4b10-bd8c-e4e94130de87"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-5808-0)", "package_ndc": "50090-5808-0", "marketing_start_date": "20211015"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-5808-2)", "package_ndc": "50090-5808-2", "marketing_start_date": "20211015"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-5808-3)", "package_ndc": "50090-5808-3", "marketing_start_date": "20211015"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (50090-5808-4)", "package_ndc": "50090-5808-4", "marketing_start_date": "20211015"}], "brand_name": "GEMFIBROZIL", "product_id": "50090-5808_b54f187d-2cb7-4fb7-9fae-2fc9e812667a", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "product_ndc": "50090-5808", "generic_name": "Gemfibrozil", "labeler_name": "A-S Medication Solutions", "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"}