FDA.reportPublic FDA data

Ambien CR 12.5 MG Extended Release Oral Tablet

RxCUI
854882
RxNorm name
Ambien CR 12.5 MG Extended Release Oral Tablet
Display name
Ambien CR 12.5 MG Extended Release Oral Tablet
Full name
Ambien CR 12.5 MG Extended Release Oral Tablet
Term type
SY
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: 854882

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
404c858c-89ac-4c9d-8a96-8702a28e6e76AMBIEN CR 12.5 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 12.5 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 12.5 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 12.5 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
40f9a7b1-b57b-4e70-b709-e81705e784a7AMBIEN CR 12.5 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 12.5 MG Extended Release Oral Tablet [SY]32These 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: 199220120430
2d934da3-bd77-4470-e063-6294a90a64f5AMBIEN CR 12.5 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 12.5 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 12.5 MG Extended Release Oral Tablet [PSN] · zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien] [SBD] · Ambien CR 12.5 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