Zolpidem Tartrate

Product NDC
72162-2441
11-digit product format
721622441
Labeler code
72162
Product ID
72162-2441_5648ce94-ab6e-40c5-a40e-fa90d79e3c89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204170
Marketing category
ANDA
Marketing start
2017-05-15
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
72162-2441-1Zolpidem Tartrate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100101
72162-2441-3Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2441ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250116_8425be72-2bbe-4090-b00e-610f1a1646b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN8425be72-2bbe-4090-b00e-610f1a1646b1101
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD8425be72-2bbe-4090-b00e-610f1a1646b1101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2441-172162244101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-1) 2025-01-15NoNoCurrent
72162-2441-37216224410330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-3) 2025-01-15NoNoCurrent