FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
21695-507
11-digit product format
216950507
Labeler code
21695
Product ID
21695-507_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
10 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
21695-507-072019-09-24C16284748780-1934fe258-4c77-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS ZOLPIDEM TARTRATE tablet for oral use - CIV Initial U.S. Approval: 1992
21695-507-102019-09-24C16284748780-1934fe258-4c77-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS ZOLPIDEM TARTRATE tablet for oral use - CIV Initial U.S. Approval: 1992
21695-507-152019-09-24C16284748780-1934fe258-4c77-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS ZOLPIDEM TARTRATE tablet for oral use - CIV Initial U.S. Approval: 1992
21695-507-302019-09-24C16284748780-1934fe258-4c77-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS ZOLPIDEM TARTRATE tablet for oral use - CIV Initial U.S. Approval: 1992
21695-507-602019-09-24C16284748780-1934fe258-4c77-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS ZOLPIDEM TARTRATE tablet for oral use - CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-507-07ZOLPIDEM TARTRATE7 in 1 BOTTLETABLET71
21695-507-10ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET101
21695-507-15ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET151
21695-507-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET301
21695-507-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-507-07EA - Each21695-50754cdc530-7875-42d9-8c31-7b03b410996b12012-07-24
21695-507-10EA - Each21695-5079438ba34-0ae2-4d4f-b757-c8fc3806ee1412012-07-24
21695-507-15EA - Each21695-5072b5deb36-478a-4199-bcb5-f0cb314bba2812012-07-24
21695-507-30EA - Each21695-507236fdcda-cc25-4970-b3e4-d35070067e9112012-07-24
21695-507-60EA - Each21695-507c8665396-6ae9-4492-aed5-7f32e863702412012-07-24

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
21695-507ZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 5 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
21695-507-07216950507077 in 1 BOTTLEHistorical
21695-507-102169505071010 in 1 BOTTLEHistorical
21695-507-152169505071515 in 1 BOTTLEHistorical
21695-507-302169505073030 in 1 BOTTLEHistorical
21695-507-602169505076060 in 1 BOTTLEHistorical