FDA.reportPublic FDA data

Ambien

Product NDC
0024-5401
11-digit product format
000245401
Labeler code
0024
Product ID
0024-5401_3d6feaca-4f30-4ca9-a9c8-d9038744fa2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA019908
Marketing category
NDA
Marketing start
1993-04-01
Marketing end
2026-10-31
Substance
ZOLPIDEM TARTRATE
Active strength
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873, 854875, 854876, 854878

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
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
0024-5401-312024-08-20C16284748780-11030e364-faf7-111a-e063-dadaa90a10e2These 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: 1992
0024-5401-312024-07-30C16284748780-11030e364-faf7-111a-e063-dadaa90a10e2These 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: 1992
0024-5401-312024-01-30C16284748780-11030e364-faf7-111a-e063-dadaa90a10e2These 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: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5401-31Ambien100 in 1 BOTTLETABLET, FILM COATED10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5401-31EA - Each0024-54016bde52e1-6dcb-4d9b-9751-f51972a3799312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
zolpidem tartrateACTIVE INGREDIENTWY6W63843KAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
zolpidemACTIVE MOIETY7K383OQI23AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WOAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
lactoseINACTIVE INGREDIENTJ2B2A4N98GAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
magnesium stearateINACTIVE INGREDIENT70097M6I30AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]10
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
ZOLPIDEMACTIVE MOIETY7K383OQI23AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
zolpidem tartrateACTIVE INGREDIENTWY6W63843KAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
zolpidemACTIVE MOIETY7K383OQI23AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5401AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]26Current NDC, Legacy NDC, 1 package rows20250418_c36cadf4-65a4-4466-b409-c82020b42452.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854875AMBIEN 10 MG Oral TabletPSNc36cadf4-65a4-4466-b409-c82020b4245226
854878AMBIEN 5 MG Oral TabletPSNc36cadf4-65a4-4466-b409-c82020b4245226
854873zolpidem tartrate 10 MG Oral TabletPSNc36cadf4-65a4-4466-b409-c82020b4245226
854876zolpidem tartrate 5 MG Oral TabletPSNc36cadf4-65a4-4466-b409-c82020b4245226
854875zolpidem tartrate 10 MG Oral Tablet [Ambien]SBDc36cadf4-65a4-4466-b409-c82020b4245226
854878zolpidem tartrate 5 MG Oral Tablet [Ambien]SBDc36cadf4-65a4-4466-b409-c82020b4245226
854873zolpidem tartrate 10 MG Oral TabletSCDc36cadf4-65a4-4466-b409-c82020b4245226
854876zolpidem tartrate 5 MG Oral TabletSCDc36cadf4-65a4-4466-b409-c82020b4245226
854875Ambien 10 MG Oral TabletSYc36cadf4-65a4-4466-b409-c82020b4245226
854878Ambien 5 MG Oral TabletSYc36cadf4-65a4-4466-b409-c82020b4245226
854875AMBIEN 10 MG Oral TabletPSN02b5e3bb-c976-40a3-9077-64ffe637429f3
854878AMBIEN 5 MG Oral TabletPSN02b5e3bb-c976-40a3-9077-64ffe637429f3
854873zolpidem tartrate 10 MG Oral TabletPSN02b5e3bb-c976-40a3-9077-64ffe637429f3
854876zolpidem tartrate 5 MG Oral TabletPSN02b5e3bb-c976-40a3-9077-64ffe637429f3
854875zolpidem tartrate 10 MG Oral Tablet [Ambien]SBD02b5e3bb-c976-40a3-9077-64ffe637429f3
854878zolpidem tartrate 5 MG Oral Tablet [Ambien]SBD02b5e3bb-c976-40a3-9077-64ffe637429f3
854873zolpidem tartrate 10 MG Oral TabletSCD02b5e3bb-c976-40a3-9077-64ffe637429f3
854876zolpidem tartrate 5 MG Oral TabletSCD02b5e3bb-c976-40a3-9077-64ffe637429f3
854875Ambien 10 MG Oral TabletSY02b5e3bb-c976-40a3-9077-64ffe637429f3
854878Ambien 5 MG Oral TabletSY02b5e3bb-c976-40a3-9077-64ffe637429f3
854875AMBIEN 10 MG Oral TabletPSN9dea009e-d435-4268-ab25-cf48a6c69abb1
854878AMBIEN 5 MG Oral TabletPSN9dea009e-d435-4268-ab25-cf48a6c69abb1
854873zolpidem tartrate 10 MG Oral TabletPSN9dea009e-d435-4268-ab25-cf48a6c69abb1
854876zolpidem tartrate 5 MG Oral TabletPSN9dea009e-d435-4268-ab25-cf48a6c69abb1
854875zolpidem tartrate 10 MG Oral Tablet [Ambien]SBD9dea009e-d435-4268-ab25-cf48a6c69abb1
854878zolpidem tartrate 5 MG Oral Tablet [Ambien]SBD9dea009e-d435-4268-ab25-cf48a6c69abb1
854873zolpidem tartrate 10 MG Oral TabletSCD9dea009e-d435-4268-ab25-cf48a6c69abb1
854876zolpidem tartrate 5 MG Oral TabletSCD9dea009e-d435-4268-ab25-cf48a6c69abb1
854875Ambien 10 MG Oral TabletSY9dea009e-d435-4268-ab25-cf48a6c69abb1
854878Ambien 5 MG Oral TabletSY9dea009e-d435-4268-ab25-cf48a6c69abb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-5401-3100024540131100 TABLET, FILM COATED in 1 BOTTLE (0024-5401-31) 1993-04-012026-10-31NoNoCurrent