FDA.reportPublic FDA data

Zolpidem

Product NDC
71335-9684
11-digit product format
713359684
Labeler code
71335
Product ID
71335-9684_dd311612-26be-4837-ab16-7be1e84fc397
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolpidem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873

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
71335-9684-0Zolpidem5 in 1 BOTTLETABLET5102
71335-9684-1Zolpidem30 in 1 BOTTLETABLET30102
71335-9684-2Zolpidem60 in 1 BOTTLETABLET60102
71335-9684-3Zolpidem100 in 1 BOTTLETABLET100102
71335-9684-4Zolpidem50 in 1 BOTTLETABLET50102
71335-9684-5Zolpidem90 in 1 BOTTLETABLET90102
71335-9684-6Zolpidem10 in 1 BOTTLETABLET10102
71335-9684-7Zolpidem15 in 1 BOTTLETABLET15102
71335-9684-8Zolpidem28 in 1 BOTTLETABLET28102
71335-9684-9Zolpidem120 in 1 BOTTLETABLET120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9684ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [BRYANT RANCH PREPACK]102Current NDC, 10 package rows20240830_74c4e793-3444-4d3d-8211-26374349ab1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN74c4e793-3444-4d3d-8211-26374349ab1e102
854873zolpidem tartrate 10 MG Oral TabletSCD74c4e793-3444-4d3d-8211-26374349ab1e102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9684-0713359684005 TABLET in 1 BOTTLE (71335-9684-0) 5 tablet2024-04-03NoNoHistorical
71335-9684-17133596840130 TABLET in 1 BOTTLE (71335-9684-1) 30 tablet2023-05-30NoNoHistorical
71335-9684-27133596840260 TABLET in 1 BOTTLE (71335-9684-2) 60 tablet2024-04-03NoNoHistorical
71335-9684-371335968403100 TABLET in 1 BOTTLE (71335-9684-3) 100 tablet2024-04-03NoNoHistorical
71335-9684-47133596840450 TABLET in 1 BOTTLE (71335-9684-4) 50 tablet2024-04-03NoNoHistorical
71335-9684-57133596840590 TABLET in 1 BOTTLE (71335-9684-5) 90 tablet2023-04-18NoNoHistorical
71335-9684-67133596840610 TABLET in 1 BOTTLE (71335-9684-6) 10 tablet2023-05-05NoNoHistorical
71335-9684-77133596840715 TABLET in 1 BOTTLE (71335-9684-7) 15 tablet2023-04-17NoNoHistorical
71335-9684-87133596840828 TABLET in 1 BOTTLE (71335-9684-8) 28 tablet2024-04-03NoNoHistorical
71335-9684-971335968409120 TABLET in 1 BOTTLE (71335-9684-9) 120 tablet2024-04-03NoNoHistorical