ezetimibe and simvastatin (69238-1158)

Drug Facts

Product Profile

Brand Name ezetimibe and simvastatin

Generic Name ezetimibe and simvastatin

Labeler amneal pharmaceuticals ny llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ezetimibe 10 mg/1, simvastatin 80 mg/1

Manufacturer

Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1158

Product ID 69238-1158_331b2e88-9d76-4e41-bca7-bcff0e206614

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208831

Listing Expiration 2026-12-31

Marketing Start 2017-11-21

Pharmacologic Class

Established (EPC)

dietary cholesterol absorption inhibitor [epc] hmg-coa reductase inhibitor [epc]

Mechanism of Action

hydroxymethylglutaryl-coa reductase inhibitors [moa]

Physiologic Effect

decreased cholesterol absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381158

Hyphenated Format 69238-1158

Supplemental Identifiers

RxCUI

476345 476349 476350 476351

UPC

0369238115833

UNII

EOR26LQQ24 AGG2FN16EV

NUI

N0000008553 N0000175911 N0000175589 N0000000121

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 and simvastatin (source: ndc)

Generic Name ezetimibe and simvastatin (source: ndc)

Application Number ANDA208831 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
80 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (69238-1158-3)
90 TABLET in 1 BOTTLE (69238-1158-9)

source: ndc

Packages (2)

69238-1158-3 30 TABLET in 1 BOTTLE (69238-1158-3) 69238-1158-9 90 TABLET in 1 BOTTLE (69238-1158-9)

Ingredients (2)

ezetimibe (10 mg/1) simvastatin (80 mg/1)

Linked Drug Pages (1)

Ezetimibe and Simvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "331b2e88-9d76-4e41-bca7-bcff0e206614", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "upc": ["0369238115833"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476345", "476349", "476350", "476351"], "spl_set_id": ["5ea3ca31-cfee-4978-8b7a-755986f6b091"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]", "HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69238-1158-3)", "package_ndc": "69238-1158-3", "marketing_start_date": "20171121"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69238-1158-9)", "package_ndc": "69238-1158-9", "marketing_start_date": "20171121"}], "brand_name": "Ezetimibe and Simvastatin", "product_id": "69238-1158_331b2e88-9d76-4e41-bca7-bcff0e206614", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]", "HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "69238-1158", "generic_name": "Ezetimibe and Simvastatin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe and Simvastatin", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}, {"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA208831", "marketing_category": "ANDA", "marketing_start_date": "20171121", "listing_expiration_date": "20261231"}