ZOLPIDEM TARTRATE

Product NDC
21695-506
11-digit product format
216950506
Labeler code
21695
Product ID
21695-506_c25ff551-9b15-4348-8d8b-9aeafe264d16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-506-07ZOLPIDEM TARTRATE7 in 1 BOTTLETABLET71
21695-506-15ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET151
21695-506-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET301
21695-506-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-506-07EA - Each21695-506b5c75f38-01c2-43e5-b275-6e80577e0ffb12012-07-24
21695-506-15EA - Each21695-506bd07aa21-185d-499b-869a-b31bbc816a3c12012-07-24
21695-506-30EA - Each21695-50680ee0a5c-3127-4303-857d-71bfed92641612012-07-24
21695-506-60EA - Each21695-5068fd4a5d4-33f3-4cc3-bbc3-bbc97165d78812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-506ZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 4 package rows20100315_7efb19d9-32bb-4737-ac7f-2ec21eca255c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854876zolpidem tartrate 5 MG Oral TabletPSN7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854873zolpidem tartrate 10 MG Oral TabletSCD7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854876zolpidem tartrate 5 MG Oral TabletSCD7efb19d9-32bb-4737-ac7f-2ec21eca255c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-506-07216950506077 in 1 BOTTLEHistorical
21695-506-152169505061515 in 1 BOTTLEHistorical
21695-506-302169505063030 in 1 BOTTLEHistorical
21695-506-602169505066060 in 1 BOTTLEHistorical