ezetimibe

Generic: ezetimibe

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-298
Product ID 50268-298_484a0aba-8404-df2e-e063-6394a90aea0b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208803
Listing Expiration 2027-12-31
Marketing Start 2017-07-02

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 50268298
Hyphenated Format 50268-298

Supplemental Identifiers

RxCUI
349556
UNII
EOR26LQQ24
NUI
N0000008553 N0000175911

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
  • 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-298-12) / 1 TABLET in 1 BLISTER PACK (50268-298-11)
source: ndc

Packages (1)

50268-298-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-298-12) / 1 TABLET in 1 BLISTER PACK (50268-298-11)

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": "484a0aba-8404-df2e-e063-6394a90aea0b", "openfda": {"nui": ["N0000008553", "N0000175911"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["6fcbfbd9-6e09-8224-e053-2a91aa0a8226"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-298-12)  / 1 TABLET in 1 BLISTER PACK (50268-298-11)", "package_ndc": "50268-298-12", "marketing_start_date": "20170702"}], "brand_name": "Ezetimibe", "product_id": "50268-298_484a0aba-8404-df2e-e063-6394a90aea0b", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "50268-298", "generic_name": "Ezetimibe", "labeler_name": "AvPAK", "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": "20170702", "listing_expiration_date": "20271231"}