ezetimibe and simvastatin (59651-837)

Drug Facts

Product Profile

Brand Name ezetimibe and simvastatin

Generic Name ezetimibe and simvastatin

Labeler aurobindo pharma limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ezetimibe 10 mg/1, simvastatin 40 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-837

Product ID 59651-837_0d4244dd-a226-4677-a6b2-6a1b5cd88790

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200082

Listing Expiration 2026-12-31

Marketing Start 2024-03-01

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 59651837

Hyphenated Format 59651-837

Supplemental Identifiers

RxCUI

476345 476349 476350 476351

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 ANDA200082 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
40 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (59651-837-30)
90 TABLET in 1 BOTTLE (59651-837-90)

source: ndc

Packages (2)

59651-837-30 30 TABLET in 1 BOTTLE (59651-837-30) 59651-837-90 90 TABLET in 1 BOTTLE (59651-837-90)

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": "0d4244dd-a226-4677-a6b2-6a1b5cd88790", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476345", "476349", "476350", "476351"], "spl_set_id": ["79dadfde-35c7-4937-9c82-1728fb6be2fb"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-837-30)", "package_ndc": "59651-837-30", "marketing_start_date": "20240301"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (59651-837-90)", "package_ndc": "59651-837-90", "marketing_start_date": "20240301"}], "brand_name": "Ezetimibe and Simvastatin", "product_id": "59651-837_0d4244dd-a226-4677-a6b2-6a1b5cd88790", "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": "59651-837", "generic_name": "Ezetimibe and Simvastatin", "labeler_name": "Aurobindo Pharma Limited", "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": "ANDA200082", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}