ezetimibe

Generic: ezetimibe

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3713
Product ID 0591-3713_24aaf5ca-08e0-4db8-9734-cf2a606f8e57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200831
Marketing Start 2017-06-12
Marketing End 2026-07-31

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 05913713
Hyphenated Format 0591-3713

Supplemental Identifiers

RxCUI
349556
UPC
0305913713307
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 ANDA200831 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (0591-3713-05)
  • 90 TABLET in 1 BOTTLE (0591-3713-19)
  • 30 TABLET in 1 BOTTLE (0591-3713-30)
source: ndc

Packages (3)

0591-3713-05 500 TABLET in 1 BOTTLE (0591-3713-05) 0591-3713-19 90 TABLET in 1 BOTTLE (0591-3713-19) 0591-3713-30 30 TABLET in 1 BOTTLE (0591-3713-30)

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": "24aaf5ca-08e0-4db8-9734-cf2a606f8e57", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0305913713307"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["f26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (0591-3713-05)", "package_ndc": "0591-3713-05", "marketing_end_date": "20260731", "marketing_start_date": "20170612"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0591-3713-19)", "package_ndc": "0591-3713-19", "marketing_end_date": "20260731", "marketing_start_date": "20170612"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (0591-3713-30)", "package_ndc": "0591-3713-30", "marketing_end_date": "20260731", "marketing_start_date": "20170612"}], "brand_name": "Ezetimibe", "product_id": "0591-3713_24aaf5ca-08e0-4db8-9734-cf2a606f8e57", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "0591-3713", "generic_name": "Ezetimibe", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA200831", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20170612"}