45963-565

Generic: Ezetimibe and Simvastatin

Labeler: Actavis Pharma, Inc.
NDC Directory DRUG FOR FURTHER PROCESSING DRUG FOR FURTHER PROCESSING Inactive

Drug Facts

Product Profile

Brand Name
Generic Name Ezetimibe and Simvastatin
Labeler Actavis Pharma, Inc.
Dosage Form TABLET
Active Ingredients

EZETIMIBE 10 mg/1, SIMVASTATIN 10 mg/1

Identifiers & Regulatory

Product NDC 45963-565
Product ID 45963-565_1cdf591a-b169-4131-b000-b975fe2c9820
Product Type DRUG FOR FURTHER PROCESSING
Marketing Category DRUG FOR FURTHER PROCESSING
Marketing Start 2017-04-26
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963565
Hyphenated Format 45963-565

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: label)
Generic Name Ezetimibe and Simvastatin (source: ndc)
Application Number ANDA202968 (source: label)
Routes
oral
source: label

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 5000 TABLET in 1 BOX (45963-565-00)
source: ndc

Packages (1)

45963-565-00 5000 TABLET in 1 BOX (45963-565-00)

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 
{"spl_id": "1cdf591a-b169-4131-b000-b975fe2c9820", "openfda": {}, "finished": false, "packaging": [{"description": "5000 TABLET in 1 BOX (45963-565-00)", "package_ndc": "45963-565-00", "marketing_end_date": "28-FEB-26", "marketing_start_date": "26-APR-17"}], "product_id": "45963-565_1cdf591a-b169-4131-b000-b975fe2c9820", "dosage_form": "TABLET", "product_ndc": "45963-565", "generic_name": "Ezetimibe and Simvastatin", "labeler_name": "Actavis Pharma, Inc.", "product_type": "DRUG FOR FURTHER PROCESSING", "brand_name_base": null, "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}, {"name": "SIMVASTATIN", "strength": "10 mg/1"}], "marketing_category": "DRUG FOR FURTHER PROCESSING", "marketing_end_date": "20260228", "marketing_start_date": "20170426"}