Ezetimibe and Simvastatin (45963-568)

Drug Facts

Product Profile

Brand Name Ezetimibe and Simvastatin

Generic Name Ezetimibe and Simvastatin

Labeler Actavis Pharma, Inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

EZETIMIBE 10 mg/1, SIMVASTATIN 80 mg/1

Identifiers & Regulatory

Product NDC 45963-568

Product ID 45963-568_bd64aee1-c95f-4767-8d31-af93dd0ab692

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202968

Marketing Start 2017-04-26

Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963568

Hyphenated Format 45963-568

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 ANDA202968 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
80 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (45963-568-08)
30 TABLET in 1 BOTTLE (45963-568-30)

source: ndc

Packages (2)

45963-568-08 90 TABLET in 1 BOTTLE (45963-568-08) 45963-568-30 30 TABLET in 1 BOTTLE (45963-568-30)

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

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