ezetimibe

Generic: ezetimibe

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-787
Product ID 10135-787_43046023-125e-85f6-e063-6294a90ab8c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215693
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 10135787
Hyphenated Format 10135-787

Supplemental Identifiers

RxCUI
349556
UPC
0310135787302 0310135787906
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 ANDA215693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (10135-787-05)
  • 30 TABLET in 1 BOTTLE (10135-787-30)
  • 90 TABLET in 1 BOTTLE (10135-787-90)
source: ndc

Packages (3)

10135-787-05 500 TABLET in 1 BOTTLE (10135-787-05) 10135-787-30 30 TABLET in 1 BOTTLE (10135-787-30) 10135-787-90 90 TABLET in 1 BOTTLE (10135-787-90)

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": "43046023-125e-85f6-e063-6294a90ab8c7", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0310135787302", "0310135787906"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["109a22f4-a7cb-96c6-e063-6394a90ad7f6"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (10135-787-05)", "package_ndc": "10135-787-05", "marketing_start_date": "20240101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (10135-787-30)", "package_ndc": "10135-787-30", "marketing_start_date": "20240101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (10135-787-90)", "package_ndc": "10135-787-90", "marketing_start_date": "20240101"}], "brand_name": "Ezetimibe", "product_id": "10135-787_43046023-125e-85f6-e063-6294a90ab8c7", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "10135-787", "generic_name": "Ezetimibe", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA215693", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}