ezetimibe and simvastatin (50090-7047)

Drug Facts

Product Profile

Brand Name ezetimibe and simvastatin

Generic Name ezetimibe and simvastatin

Labeler a-s medication solutions

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ezetimibe 10 mg/1, simvastatin 40 mg/1

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7047

Product ID 50090-7047_2a454f7c-e824-4504-b2e8-5fce64b1065a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208699

Listing Expiration 2026-12-31

Marketing Start 2019-08-19

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 500907047

Hyphenated Format 50090-7047

Supplemental Identifiers

RxCUI

476350

UNII

EOR26LQQ24 AGG2FN16EV

NUI

N0000008553 N0000175911 N0000175589 N0000000121

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 ANDA208699 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
40 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (50090-7047-0)

source: ndc

Packages (1)

50090-7047-0 90 TABLET in 1 BOTTLE (50090-7047-0)

Ingredients (2)

ezetimibe (10 mg/1) simvastatin (40 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": "2a454f7c-e824-4504-b2e8-5fce64b1065a", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476350"], "spl_set_id": ["2c936363-b483-46c6-936c-a07d8ab0280c"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-7047-0)", "package_ndc": "50090-7047-0", "marketing_start_date": "20240115"}], "brand_name": "ezetimibe and simvastatin", "product_id": "50090-7047_2a454f7c-e824-4504-b2e8-5fce64b1065a", "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": "50090-7047", "generic_name": "ezetimibe and simvastatin", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ezetimibe and simvastatin", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}, {"name": "SIMVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA208699", "marketing_category": "ANDA", "marketing_start_date": "20190819", "listing_expiration_date": "20261231"}