NDC 57664-515-88 - 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: 57664-515
Requested NDC: 57664-515-88
Package NDCs from labels: 57664-515-88, 57664-515-13, 57664-515-18
Manufacturer: Caraco Pharmaceutical Laboratories, Ltd.
Effective date: 2008-09-18
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 - Caraco Pharmaceutical Laboratories, Ltd.	Caraco Pharmaceutical Laboratories, Ltd.	2008-09-18	HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-515-13	EA - Each	57664-515	213a8619-0679-44af-8353-4a4be80b342d	1	2013-02-13
57664-515-18	EA - Each	57664-515	16d9443b-77ee-460a-8b5b-c52b00d6cf39	1	2013-02-13
57664-515-88	EA - Each	57664-515	e2e0ac64-3f5e-4e38-af6d-37d905373e26	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 TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
zolpidem	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
hypromellose	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
iron oxide black	INACTIVE INGREDIENT	XM0M87F357	ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
iron oxide red	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
microcrystalline cellulose	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
Polysorbate 80	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
sodium starch glycolate	INACTIVE INGREDIENT		ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	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
4219CF23-5CD1-F8D8-8F59-5143827EFB8A			208db529-ae52-462d-8fd2-775b11ce6350	2008-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 4219CF23-5CD1-F8D8-8F59-5143827EFB8A spl set id: 208db529-ae52-462d-8fd2-775b11ce6350

Reported adverse events (FAERS/openFDA)#

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