ezetimibe and simvastatin (51407-192)

Drug Facts

Product Profile

Brand Name ezetimibe and simvastatin

Generic Name ezetimibe and simvastatin

Labeler golden state medical supply, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ezetimibe 10 mg/1, simvastatin 40 mg/1

Manufacturer

Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-192

Product ID 51407-192_446023ff-25b4-2c12-e063-6294a90ad27e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200909

Marketing Start 2017-04-26

Marketing End 2027-09-30

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 51407192

Hyphenated Format 51407-192

Supplemental Identifiers

RxCUI

476345 476349 476350 476351

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 ANDA200909 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
40 mg/1

source: ndc

Packaging

500 TABLET in 1 BOTTLE (51407-192-05)
30 TABLET in 1 BOTTLE (51407-192-30)

source: ndc

Packages (2)

51407-192-05 500 TABLET in 1 BOTTLE (51407-192-05) 51407-192-30 30 TABLET in 1 BOTTLE (51407-192-30)

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": "446023ff-25b4-2c12-e063-6294a90ad27e", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476345", "476349", "476350", "476351"], "spl_set_id": ["88cd0e7b-e8dc-6125-e053-2a95a90aaa27"], "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": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (51407-192-05)", "package_ndc": "51407-192-05", "marketing_end_date": "20260331", "marketing_start_date": "20190429"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (51407-192-30)", "package_ndc": "51407-192-30", "marketing_end_date": "20270930", "marketing_start_date": "20190429"}], "brand_name": "Ezetimibe and Simvastatin", "product_id": "51407-192_446023ff-25b4-2c12-e063-6294a90ad27e", "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": "51407-192", "generic_name": "Ezetimibe and Simvastatin", "labeler_name": "Golden State Medical Supply, Inc.", "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": "ANDA200909", "marketing_category": "ANDA", "marketing_end_date": "20270930", "marketing_start_date": "20170426"}