FDA.reportPublic FDA data

Ambien

Product NDC
21695-211
11-digit product format
216950211
Labeler code
21695
Product ID
21695-211_c298d925-bf40-442d-9041-dea5c50fb60b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
NDA019908
Marketing category
NDA
Marketing start
2009-06-30
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
5 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-211-152019-09-24C16284748780-1934fe258-477c-48b1-e053-8cdaa90a720aThese 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: 1992
21695-211-302019-09-24C16284748780-1934fe258-477c-48b1-e053-8cdaa90a720aThese 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: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-211-15Ambien15 in 1 BOTTLETABLET, FILM COATED151
21695-211-30Ambien30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-211-15EA - Each21695-211b6ff5c89-25eb-4b6b-a212-a660a7b611dc12012-07-24
21695-211-30EA - Each21695-21157a4fb70-ca36-48ec-b801-c5aac3bacfe912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
21695-211AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100629_9dea009e-d435-4268-ab25-cf48a6c69abb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
21695-211-152169502111515 in 1 BOTTLEHistorical
21695-211-302169502113030 in 1 BOTTLEHistorical