FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
50090-3879
11-digit product format
500903879
Labeler code
50090
Product ID
50090-3879_dfbb76f7-d5d5-4379-9495-3e77b1e9a663
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
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 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
50090-3879-0Zolpidem Tartrate20 in 1 BOTTLETABLET, FILM COATED2015
50090-3879-1Zolpidem Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015
50090-3879-2Zolpidem Tartrate10 in 1 BOTTLETABLET, FILM COATED1015
50090-3879-3Zolpidem Tartrate3 in 1 BOTTLE, PLASTICTABLET, FILM COATED315
50090-3879-4Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3879-0EA - Each50090-3879148b1a66-50ba-4349-8336-c5bdc7676ef112024-08-12
50090-3879-1EA - Each50090-3879d65a8d16-e1d8-4a1d-8c63-f2840b013aa012021-12-08
50090-3879-2EA - Each50090-38794c28d68f-9037-4ba9-b5c1-6d5d7dd86a4b12021-12-08
50090-3879-3EA - Each50090-3879eeb1dec3-af57-4d0a-affa-ed158ca94b2212021-12-08
50090-3879-4EA - Each50090-387995a8e516-9a02-4ece-ae04-ea244783391c12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3879ZOLPIDEM TARTRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 5 package rows20250502_91511d2f-7066-49a0-90ea-2940d955c85e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN91511d2f-7066-49a0-90ea-2940d955c85e15
854876zolpidem tartrate 5 MG Oral TabletSCD91511d2f-7066-49a0-90ea-2940d955c85e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3879-05009038790020 TABLET, FILM COATED in 1 BOTTLE (50090-3879-0) 2018-11-280000-00-00NoNoCurrent
50090-3879-15009038790130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3879-1) 2014-11-280000-00-00NoNoCurrent
50090-3879-25009038790210 TABLET, FILM COATED in 1 BOTTLE (50090-3879-2) 2018-11-280000-00-00NoNoCurrent
50090-3879-3500903879033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3879-3) 2014-11-280000-00-00NoNoCurrent
50090-3879-45009038790460 TABLET, FILM COATED in 1 BOTTLE (50090-3879-4) 2018-11-280000-00-00NoNoCurrent