FDA.reportPublic FDA data

Ambien

Product NDC
0024-5521
11-digit product format
000245521
Labeler code
0024
Product ID
0024-5521_3781baee-63d5-40a7-bc44-fc72d1adca32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA021774
Marketing category
NDA
Marketing start
2005-09-19
Marketing end
2026-07-31
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ambien
Brand name suffix
CR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880, 854882, 854894, 854896

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0024-5521-102024-08-20C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-312024-08-20C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-502024-08-20C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-102024-07-30C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-312024-07-30C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-502024-07-30C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-102024-01-30C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-312024-01-30C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992
0024-5521-502024-01-30C16284748780-11030e365-5bf0-111a-e063-dadaa90a10e2These 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: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5521-10AmbienCR10 in 1 BLISTER PACKTABLET, COATED1030
0024-5521-10AmbienCR3 in 1 CARTONTABLET, COATED330
0024-5521-31AmbienCR100 in 1 BOTTLETABLET, COATED10030
0024-5521-50AmbienCR500 in 1 BOTTLETABLET, COATED50030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5521-31EA - Each0024-55219831921e-550d-4e84-b559-22ae23c1c4cd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
zolpidem tartrateACTIVE INGREDIENTWY6W63843KAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
zolpidemACTIVE MOIETY7K383OQI23AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
ferric oxide redINACTIVE INGREDIENT1K09F3G675AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WOAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
magnesium stearateINACTIVE INGREDIENT70097M6I30AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
potassium bitartrateINACTIVE INGREDIENTNPT6P8P3UUAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]10
zolpidem tartrateACTIVE INGREDIENTWY6W63843KAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
zolpidemACTIVE MOIETY7K383OQI23AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
ferric oxide redINACTIVE INGREDIENT1K09F3G675AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
potassium bitartrateINACTIVE INGREDIENTNPT6P8P3UUAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]4
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
ZOLPIDEMACTIVE MOIETY7K383OQI23AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
POTASSIUM BITARTRATEINACTIVE INGREDIENTNPT6P8P3UUAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [STAT RX USA LLC]2
zolpidem tartrateACTIVE INGREDIENTWY6W63843KAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
zolpidemACTIVE MOIETY7K383OQI23AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
potassium bitartrateINACTIVE INGREDIENTNPT6P8P3UUAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5521AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [SANOFI-AVENTIS U.S. LLC]30Current NDC, Legacy NDC, 4 package rows20250418_404c858c-89ac-4c9d-8a96-8702a28e6e76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854882AMBIEN CR 12.5 MG Extended Release Oral TabletPSN404c858c-89ac-4c9d-8a96-8702a28e6e7630
854896AMBIEN CR 6.25 MG Extended Release Oral TabletPSN404c858c-89ac-4c9d-8a96-8702a28e6e7630
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN404c858c-89ac-4c9d-8a96-8702a28e6e7630
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN404c858c-89ac-4c9d-8a96-8702a28e6e7630
854882zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien]SBD404c858c-89ac-4c9d-8a96-8702a28e6e7630
854896zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]SBD404c858c-89ac-4c9d-8a96-8702a28e6e7630
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD404c858c-89ac-4c9d-8a96-8702a28e6e7630
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD404c858c-89ac-4c9d-8a96-8702a28e6e7630
854882Ambien CR 12.5 MG Extended Release Oral TabletSY404c858c-89ac-4c9d-8a96-8702a28e6e7630
854896Ambien CR 6.25 MG Extended Release Oral TabletSY404c858c-89ac-4c9d-8a96-8702a28e6e7630
854882AMBIEN CR 12.5 MG Extended Release Oral TabletPSN0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854896AMBIEN CR 6.25 MG Extended Release Oral TabletPSN0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854882zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien]SBD0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854896zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]SBD0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854882Ambien CR 12.5 MG Extended Release Oral TabletSY0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854896Ambien CR 6.25 MG Extended Release Oral TabletSY0d83cde7-4604-4bdd-a7cd-c31a5830514d4
854882AMBIEN CR 12.5 MG Extended Release Oral TabletPSN40f9a7b1-b57b-4e70-b709-e81705e784a72
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN40f9a7b1-b57b-4e70-b709-e81705e784a72
854882zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien]SBD40f9a7b1-b57b-4e70-b709-e81705e784a72
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD40f9a7b1-b57b-4e70-b709-e81705e784a72
854882Ambien CR 12.5 MG Extended Release Oral TabletSY40f9a7b1-b57b-4e70-b709-e81705e784a72
854882AMBIEN CR 12.5 MG Extended Release Oral TabletPSN968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854896AMBIEN CR 6.25 MG Extended Release Oral TabletPSN968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854882zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien]SBD968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854896zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]SBD968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854882Ambien CR 12.5 MG Extended Release Oral TabletSY968b5154-3c38-4f20-bbeb-495bcb91cc2b1
854896Ambien CR 6.25 MG Extended Release Oral TabletSY968b5154-3c38-4f20-bbeb-495bcb91cc2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-5521-100002455211010 in 1 BLISTER PACKHistorical
0024-5521-3100024552131100 TABLET, COATED in 1 BOTTLE (0024-5521-31) 2005-09-192026-07-31NoNoCurrent
0024-5521-5000024552150500 in 1 BOTTLEHistorical