FDA.reportPublic FDA data

zolpidem tartrate 10 MG Oral Tablet [Ambien]

RxCUI
854875
RxNorm name
zolpidem tartrate 10 MG Oral Tablet [Ambien]
Display name
zolpidem tartrate 10 MG Oral Tablet [Ambien]
Full name
zolpidem tartrate 10 MG Oral Tablet [Ambien]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmbienZOLPIDEM TARTRATESanofi-Aventis U.S. LLCc36cadf4-65a4-4466-b409-c82020b424522025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854875
AmbienZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.747949c5-2c91-4909-8a07-71b6826f8e972025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854875

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
c36cadf4-65a4-4466-b409-c82020b42452AMBIEN 10 MG Oral Tablet [PSN] · zolpidem tartrate 10 MG Oral Tablet [Ambien] [SBD] · Ambien 10 MG Oral Tablet [SY]326These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 199220250415
02b5e3bb-c976-40a3-9077-64ffe637429fAMBIEN 10 MG Oral Tablet [PSN] · zolpidem tartrate 10 MG Oral Tablet [Ambien] [SBD] · Ambien 10 MG Oral Tablet [SY]33These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 199220120918
747949c5-2c91-4909-8a07-71b6826f8e97AMBIEN 10 MG Oral Tablet [PSN] · zolpidem tartrate 10 MG Oral Tablet [Ambien] [SBD] · Ambien 10 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 199220250207
9dea009e-d435-4268-ab25-cf48a6c69abbAMBIEN 10 MG Oral Tablet [PSN] · zolpidem tartrate 10 MG Oral Tablet [Ambien] [SBD] · Ambien 10 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 199220090701