ezetimibe

Generic: ezetimibe

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler sciegen pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-379
Product ID 50228-379_1ab4be5f-4926-88ad-e063-6294a90a0c81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210673
Listing Expiration 2026-12-31
Marketing Start 2020-10-23

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 50228379
Hyphenated Format 50228-379

Supplemental Identifiers

RxCUI
349556
UPC
0350228379106 0350228379052 0350228379908 0350228379304
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 ANDA210673 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (50228-379-05)
  • 1000 TABLET in 1 BOTTLE (50228-379-10)
  • 30 TABLET in 1 BOTTLE (50228-379-30)
  • 90 TABLET in 1 BOTTLE (50228-379-90)
source: ndc

Packages (4)

50228-379-05 500 TABLET in 1 BOTTLE (50228-379-05) 50228-379-10 1000 TABLET in 1 BOTTLE (50228-379-10) 50228-379-30 30 TABLET in 1 BOTTLE (50228-379-30) 50228-379-90 90 TABLET in 1 BOTTLE (50228-379-90)

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": "1ab4be5f-4926-88ad-e063-6294a90a0c81", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0350228379106", "0350228379052", "0350228379908", "0350228379304"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["11de499b-ad8a-46a6-9021-c8eba72ae414"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-379-05)", "package_ndc": "50228-379-05", "marketing_start_date": "20201023"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-379-10)", "package_ndc": "50228-379-10", "marketing_start_date": "20201023"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-379-30)", "package_ndc": "50228-379-30", "marketing_start_date": "20201023"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50228-379-90)", "package_ndc": "50228-379-90", "marketing_start_date": "20201023"}], "brand_name": "Ezetimibe", "product_id": "50228-379_1ab4be5f-4926-88ad-e063-6294a90a0c81", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "50228-379", "generic_name": "Ezetimibe", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA210673", "marketing_category": "ANDA", "marketing_start_date": "20201023", "listing_expiration_date": "20261231"}