ZOLPIDEM TARTRATE

Product NDC
60760-515
11-digit product format
607600515
Labeler code
60760
Product ID
60760-515_4ddfd698-3d48-fc0e-e063-6394a90accec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
St Marys Medical Park Pharmacy
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854876

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-515-30ZOLPIDEM TARTRATE30 in 1 BOTTLE, PLASTICTABLET3012
60760-515-60ZOLPIDEM TARTRATE60 in 1 BOTTLE, PLASTICTABLET6012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-515ZOLPIDEM TARTRATE TABLET [ST MARYS MEDICAL PARK PHARMACY]10Current NDC, Legacy NDC, 2 package rows20231209_89cfb1d5-437c-4c13-8f9b-b6851ffba87b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN89cfb1d5-437c-4c13-8f9b-b6851ffba87b12
854876zolpidem tartrate 5 MG Oral TabletSCD89cfb1d5-437c-4c13-8f9b-b6851ffba87b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-515-306076005153030 TABLET in 1 BOTTLE, PLASTIC (60760-515-30) 30 tablet2007-09-050000-00-00NoNoCurrent
60760-515-606076005156060 TABLET in 1 BOTTLE, PLASTIC (60760-515-60) 60 tablet2025-11-240000-00-00NoNoCurrent