ezetimibe and simvastatin (16714-778)

Drug Facts

Product Profile

Brand Name ezetimibe and simvastatin

Generic Name ezetimibe and simvastatin

Labeler northstar rx llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ezetimibe 10 mg/1, simvastatin 10 mg/1

Manufacturer

NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-778

Product ID 16714-778_0d1ac067-fb51-46db-98da-5efd6a65e9e1

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 16714778

Hyphenated Format 16714-778

Supplemental Identifiers

RxCUI

476345 476349 476350 476351

UPC

0316714779010

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 ANDA208699 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (16714-778-01)
90 TABLET in 1 BOTTLE (16714-778-02)

source: ndc

Packages (2)

16714-778-01 30 TABLET in 1 BOTTLE (16714-778-01) 16714-778-02 90 TABLET in 1 BOTTLE (16714-778-02)

Ingredients (2)

ezetimibe (10 mg/1) simvastatin (10 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": "0d1ac067-fb51-46db-98da-5efd6a65e9e1", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "upc": ["0316714779010"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476345", "476349", "476350", "476351"], "spl_set_id": ["52a46269-2262-4052-a3ff-5455523f591f"], "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": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (16714-778-01)", "package_ndc": "16714-778-01", "marketing_start_date": "20190819"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (16714-778-02)", "package_ndc": "16714-778-02", "marketing_start_date": "20190819"}], "brand_name": "ezetimibe and simvastatin", "product_id": "16714-778_0d1ac067-fb51-46db-98da-5efd6a65e9e1", "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": "16714-778", "generic_name": "ezetimibe and simvastatin", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ezetimibe and simvastatin", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}, {"name": "SIMVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA208699", "marketing_category": "ANDA", "marketing_start_date": "20190819", "listing_expiration_date": "20261231"}