NDC 63672-0004-1 - Simvastatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 63672-0004
Requested NDC: 63672-0004-1
Package NDCs from labels: 63672-0004-1, 63672-0004-3
Manufacturer: Synthon Pharmaceuticals, Inc.
Effective date: 2008-01-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
SIMVASTATIN ORALLY DISINTEGRATING TABLETS (SIMVASTATIN)	Synthon Pharmaceuticals, Inc.	2008-01-23	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63672-0004-1	Simvastatin	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30		1
63672-0004-3	Simvastatin	90 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63672-0004	SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1	2 package rows	20080205_34B56F73-BEA4-4265-8B2A-C57520CF8E70.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
Simvastatin	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
butylated hydroyanisole	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
cellulose	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
crospovidone	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
glyceryl behenate	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
hydroxypropyl cellulose	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
iron oxide red	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
iron oxide yellow	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
mint menthol	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
povidone	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
silicified microcrystalline	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1
sucralose	INACTIVE INGREDIENT		SIMVASTATIN (SIMVASTATIN) TABLET, ORALLY DISINTEGRATING [SYNTHON PHARMACEUTICALS, INC.]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
577C735F-1A17-3675-7016-6AF3E48680A2			34B56F73-BEA4-4265-8B2A-C57520CF8E70	2008-01-23	Warnings, Adverse reactions	Exact identifier spl id: 577C735F-1A17-3675-7016-6AF3E48680A2 spl set id: 34B56F73-BEA4-4265-8B2A-C57520CF8E70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.