ezetimibe

Generic: ezetimibe

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1154
Product ID 69238-1154_edb9906a-4007-40ff-a3dc-3083e50545ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208803
Listing Expiration 2026-12-31
Marketing Start 2017-06-12

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 692381154
Hyphenated Format 69238-1154

Supplemental Identifiers

RxCUI
349556
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 ANDA208803 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (69238-1154-1)
  • 30 TABLET in 1 BOTTLE (69238-1154-3)
  • 500 TABLET in 1 BOTTLE (69238-1154-5)
  • 90 TABLET in 1 BOTTLE (69238-1154-9)
source: ndc

Packages (4)

69238-1154-1 1000 TABLET in 1 BOTTLE (69238-1154-1) 69238-1154-3 30 TABLET in 1 BOTTLE (69238-1154-3) 69238-1154-5 500 TABLET in 1 BOTTLE (69238-1154-5) 69238-1154-9 90 TABLET in 1 BOTTLE (69238-1154-9)

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": "edb9906a-4007-40ff-a3dc-3083e50545ae", "openfda": {"nui": ["N0000008553", "N0000175911"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["3fadf4e9-017d-4ccd-91dc-a89b981eb138"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (69238-1154-1)", "package_ndc": "69238-1154-1", "marketing_start_date": "20170612"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (69238-1154-3)", "package_ndc": "69238-1154-3", "marketing_start_date": "20170612"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69238-1154-5)", "package_ndc": "69238-1154-5", "marketing_start_date": "20170612"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69238-1154-9)", "package_ndc": "69238-1154-9", "marketing_start_date": "20170612"}], "brand_name": "Ezetimibe", "product_id": "69238-1154_edb9906a-4007-40ff-a3dc-3083e50545ae", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "69238-1154", "generic_name": "Ezetimibe", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA208803", "marketing_category": "ANDA", "marketing_start_date": "20170612", "listing_expiration_date": "20261231"}