ezetimibe

Generic: ezetimibe

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-024
Product ID 82009-024_98acb755-ad5c-414a-b9e9-6cd30c10a2e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204331
Listing Expiration 2026-12-31
Marketing Start 2022-08-20

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 82009024
Hyphenated Format 82009-024

Supplemental Identifiers

RxCUI
349556
UPC
0382009024059
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 ANDA204331 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (82009-024-05)
source: ndc

Packages (1)

82009-024-05 500 TABLET in 1 BOTTLE (82009-024-05)

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": "98acb755-ad5c-414a-b9e9-6cd30c10a2e7", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0382009024059"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["68247ce8-e812-42f2-a3ba-0f6e49acca63"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (82009-024-05)", "package_ndc": "82009-024-05", "marketing_start_date": "20220820"}], "brand_name": "ezetimibe", "product_id": "82009-024_98acb755-ad5c-414a-b9e9-6cd30c10a2e7", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "82009-024", "generic_name": "ezetimibe", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA204331", "marketing_category": "ANDA", "marketing_start_date": "20220820", "listing_expiration_date": "20261231"}