FDA.reportPublic FDA data

zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]

RxCUI
854896
RxNorm name
zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]
Display name
zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]
Full name
zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ambien CRZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.2d934da3-bd77-4470-e063-6294a90a64f52025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854896

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
404c858c-89ac-4c9d-8a96-8702a28e6e76AMBIEN CR 6.25 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 6.25 MG Extended Release Oral Tablet [SY]330These highlights do not include all the information needed to use AMBIEN CR safely and effectively. See full prescribing information for AMBIEN CR. AMBIEN CR ® (zolpidem tartrate) extended-release tablets, for oral use, C-IV Initial U.S. Approval: 199220250415
0d83cde7-4604-4bdd-a7cd-c31a5830514dAMBIEN CR 6.25 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 6.25 MG Extended Release Oral Tablet [SY]34These highlights do not include all the information needed to use Ambien CR safely and effectively. See full prescribing information for Ambien CR. Ambien CR ® (zolpidem tartrate extended-release) tablets - CIV Initial U.S. Approval: 199220120904
2d934da3-bd77-4470-e063-6294a90a64f5AMBIEN CR 6.25 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 6.25 MG Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use AMBIEN CR safely and effectively. See full prescribing information for AMBIEN CR. AMBIEN CR ® (zolpidem tartrate) extended-release tablets, for oral use, C-IV Initial U.S. Approval: 199220250207
968b5154-3c38-4f20-bbeb-495bcb91cc2bAMBIEN CR 6.25 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 6.25 MG Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use Ambien CR safely and effectively. See full prescribing information for Ambien CR. Ambien CR ® (zolpidem tartrate extended-release) tablets - CIV Initial U.S. Approval: 199220091001