Ezetimibe

Generic: Ezetimibe

Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Ezetimibe
Generic Name Ezetimibe
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

EZETIMIBE 10 mg/1

Identifiers & Regulatory

Product NDC 0615-8300
Product ID 0615-8300_e4fa3743-ceaf-46a5-b02c-954fe5944e5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209838
Marketing Start 2017-08-25
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158300
Hyphenated Format 0615-8300

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
  • 15 TABLET in 1 BLISTER PACK (0615-8300-05)
  • 30 TABLET in 1 BLISTER PACK (0615-8300-39)
source: ndc

Packages (2)

0615-8300-05 15 TABLET in 1 BLISTER PACK (0615-8300-05) 0615-8300-39 30 TABLET in 1 BLISTER PACK (0615-8300-39)

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": "e4fa3743-ceaf-46a5-b02c-954fe5944e5b", "openfda": {"nui": ["N0000008553", "N0000175911"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["f30c3cb1-fb91-4f69-b181-bfb4238635af"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-8300-05)", "package_ndc": "0615-8300-05", "marketing_end_date": "20260228", "marketing_start_date": "20230831"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8300-39)", "package_ndc": "0615-8300-39", "marketing_end_date": "20260228", "marketing_start_date": "20190703"}], "brand_name": "Ezetimibe", "product_id": "0615-8300_e4fa3743-ceaf-46a5-b02c-954fe5944e5b", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "0615-8300", "generic_name": "Ezetimibe", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA209838", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20170825"}