NDC 63672-3010 - Zolpidem tartrate

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: 63672-3010
Package NDCs from labels: 63672-3010-1, 63672-3010-2
Manufacturer: Synthon Pharmaceuticals, Inc.
Effective date: 2007-05-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Zolpidem tartrate - Synthon Pharmaceuticals, Inc.	Synthon Pharmaceuticals, Inc.	2007-05-09	HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63672-3010-1	Zolpidem tartrate	100 in 1 BOTTLE	TABLET, FILM COATED	100		1
63672-3010-2	Zolpidem tartrate	500 in 1 BOTTLE	TABLET, FILM COATED	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63672-3010	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1	2 package rows	20070614_AE0B595A-36D2-44F3-84F6-7FE9F995F4A1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63672-3010-1	EA - Each	63672-3010	a1c28e49-eee8-4be0-bf2d-6f5f6d697ccb	1	2015-10-02
63672-3010-2	EA - Each	63672-3010	392d75a6-90b1-49ee-b6fa-62f5cdc76e96	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
Zolpidem	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
hypromellose	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
iron oxide red	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
lactose	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
microcrystalline cellulose	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
polyethylene glycol	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
sodium starch glycolate	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7abb6898-223c-487b-856c-068ac04f7a5c	2018-09-25	Warnings, Adverse reactions	Exact identifier rxcui: 854876 rxcui: 854873
BCF5064B-F7DD-7A98-5D27-AD5BA1517D98			AE0B595A-36D2-44F3-84F6-7FE9F995F4A1	2007-05-09	Warnings, Adverse reactions	Exact identifier spl id: BCF5064B-F7DD-7A98-5D27-AD5BA1517D98 spl set id: AE0B595A-36D2-44F3-84F6-7FE9F995F4A1

Reported adverse events (FAERS/openFDA)#

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