zetia

Generic: ezetimibe

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zetia
Generic Name ezetimibe
Labeler organon llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-178
Product ID 78206-178_8e5eed2a-7b64-4350-9b87-500f1b04225d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021445
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 78206178
Hyphenated Format 78206-178

Supplemental Identifiers

RxCUI
349556 352304
UPC
0378206178015
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 zetia (source: ndc)
Generic Name ezetimibe (source: ndc)
Application Number NDA021445 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (78206-178-01)
source: ndc

Packages (1)

78206-178-01 30 TABLET in 1 BOTTLE (78206-178-01)

Ingredients (1)

ezetimibe (10 mg/1)

Linked Drug Pages (1)

Zetia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8e5eed2a-7b64-4350-9b87-500f1b04225d", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0378206178015"], "unii": ["EOR26LQQ24"], "rxcui": ["349556", "352304"], "spl_set_id": ["174e45e0-45bb-48b7-9e60-8f6cfc1d22bb"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (78206-178-01)", "package_ndc": "78206-178-01", "marketing_start_date": "20210601"}], "brand_name": "Zetia", "product_id": "78206-178_8e5eed2a-7b64-4350-9b87-500f1b04225d", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "78206-178", "generic_name": "Ezetimibe", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zetia", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "NDA021445", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}