Zolpidem Tartrate

Product NDC
50090-3878
11-digit product format
500903878
Labeler code
50090
Product ID
50090-3878_f0422eb4-b8c1-410e-9a32-4538f743ff92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
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 Tartrate
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
50090-3878-0Zolpidem Tartrate10 in 1 BOTTLETABLET, FILM COATED1013
50090-3878-1Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3878-0EA - Each50090-3878f6664dd4-80de-43be-b475-6819ee5e679012021-12-08
50090-3878-1EA - Each50090-38789e441bc1-8946-4f55-8676-0bcb1e4a208312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3878ZOLPIDEM TARTRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20231026_ef72eb73-d058-4ca3-9013-691aae8426fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNef72eb73-d058-4ca3-9013-691aae8426fb13
854873zolpidem tartrate 10 MG Oral TabletSCDef72eb73-d058-4ca3-9013-691aae8426fb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3878-05009038780010 TABLET, FILM COATED in 1 BOTTLE (50090-3878-0) 2018-11-280000-00-00NoNoCurrent
50090-3878-15009038780130 TABLET, FILM COATED in 1 BOTTLE (50090-3878-1) 2018-11-280000-00-00NoNoCurrent