ezetimibe

Generic: ezetimibe

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

Drug Facts

Product Profile

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

ezetimibe 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3422
Product ID 50090-3422_a1915b61-123e-406c-ba03-a6ad459829d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209838
Listing Expiration 2026-12-31
Marketing Start 2017-08-25

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 500903422
Hyphenated Format 50090-3422

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 ANDA209838 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-3422-0)
  • 90 TABLET in 1 BOTTLE (50090-3422-1)
source: ndc

Packages (2)

50090-3422-0 30 TABLET in 1 BOTTLE (50090-3422-0) 50090-3422-1 90 TABLET in 1 BOTTLE (50090-3422-1)

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": "a1915b61-123e-406c-ba03-a6ad459829d1", "openfda": {"nui": ["N0000008553", "N0000175911"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["63ecbbf1-a6de-493f-9710-812ff45cb4d3"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-3422-0)", "package_ndc": "50090-3422-0", "marketing_start_date": "20180328"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-3422-1)", "package_ndc": "50090-3422-1", "marketing_start_date": "20180403"}], "brand_name": "Ezetimibe", "product_id": "50090-3422_a1915b61-123e-406c-ba03-a6ad459829d1", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "50090-3422", "generic_name": "Ezetimibe", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA209838", "marketing_category": "ANDA", "marketing_start_date": "20170825", "listing_expiration_date": "20261231"}