ezetimibe

Generic: ezetimibe

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-226
Product ID 68462-226_5009c162-91bb-425a-a688-6237c259d33e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078560
Marketing Start 2022-04-29
Marketing End 2027-01-01

Pharmacologic Class

Established (EPC)
dietary cholesterol absorption inhibitor [epc]
Physiologic Effect
decreased cholesterol absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462226
Hyphenated Format 68462-226

Supplemental Identifiers

RxCUI
349556
UPC
0368462226308
UNII
EOR26LQQ24
NUI
N0000008553 N0000175911

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 ezetimibe (source: ndc)
Generic Name ezetimibe (source: ndc)
Application Number ANDA078560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (68462-226-05)
  • 1000 TABLET in 1 BOTTLE (68462-226-10)
  • 10 BLISTER PACK in 1 CARTON (68462-226-11) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (68462-226-30)
  • 90 TABLET in 1 BOTTLE (68462-226-90)
source: ndc

Packages (5)

68462-226-05 500 TABLET in 1 BOTTLE (68462-226-05) 68462-226-10 1000 TABLET in 1 BOTTLE (68462-226-10) 68462-226-11 10 BLISTER PACK in 1 CARTON (68462-226-11) / 10 TABLET in 1 BLISTER PACK 68462-226-30 30 TABLET in 1 BOTTLE (68462-226-30) 68462-226-90 90 TABLET in 1 BOTTLE (68462-226-90)

Ingredients (1)

ezetimibe (10 mg/1)

Linked Drug Pages (1)

Ezetimibe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5009c162-91bb-425a-a688-6237c259d33e", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0368462226308"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["ac539a72-77e4-419c-b1d9-42002e9cecf7"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-226-05)", "package_ndc": "68462-226-05", "marketing_end_date": "20270101", "marketing_start_date": "20220429"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68462-226-10)", "package_ndc": "68462-226-10", "marketing_end_date": "20270101", "marketing_start_date": "20220429"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-226-11)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68462-226-11", "marketing_end_date": "20270101", "marketing_start_date": "20220429"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68462-226-30)", "package_ndc": "68462-226-30", "marketing_end_date": "20270101", "marketing_start_date": "20220429"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68462-226-90)", "package_ndc": "68462-226-90", "marketing_end_date": "20270101", "marketing_start_date": "20220429"}], "brand_name": "Ezetimibe", "product_id": "68462-226_5009c162-91bb-425a-a688-6237c259d33e", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "68462-226", "generic_name": "Ezetimibe", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA078560", "marketing_category": "ANDA", "marketing_end_date": "20270101", "marketing_start_date": "20220429"}