ezetimibe

Generic: ezetimibe

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-211
Product ID 82804-211_55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078560
Listing Expiration 2026-12-31
Marketing Start 2022-04-29

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 82804211
Hyphenated Format 82804-211

Supplemental Identifiers

RxCUI
349556
UPC
0382804211302
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 ANDA078560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-211-30)
source: ndc

Packages (1)

82804-211-30 30 TABLET in 1 BOTTLE (82804-211-30)

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": "55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0382804211302"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-211-30)", "package_ndc": "82804-211-30", "marketing_start_date": "20250319"}], "brand_name": "Ezetimibe", "product_id": "82804-211_55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "82804-211", "generic_name": "Ezetimibe", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA078560", "marketing_category": "ANDA", "marketing_start_date": "20220429", "listing_expiration_date": "20261231"}