ZOLPIDEM TARTRATE

Product NDC
50090-1023
11-digit product format
500901023
Labeler code
50090
Product ID
50090-1023_28ebfe4f-0f11-4136-afa7-0201d1a126fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1023-02023-02-07C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-02023-02-07C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-12023-02-07C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-12023-02-07C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-22023-02-07C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-22023-02-07C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-02023-01-30C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-02023-01-30C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-12023-01-30C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-12023-01-30C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-22023-01-30C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992
50090-1023-22023-01-30C16284748780-1f386c649-c617-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C-IV Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1023-0EA - Each50090-102328fbbf88-26af-4e24-9040-cc80658c032912018-10-11
50090-1023-1EA - Each50090-102347a7b528-11f8-47fe-aa2b-792020c21aa512018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1023ZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS]28Legacy NDC20250516_59cc61da-838e-4add-b2d6-42b2b283a000.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1023-05009010230010 TABLET in 1 BOTTLE (50090-1023-0) 10 tablet2014-11-280000-00-00NoNoCurrent
50090-1023-15009010230130 TABLET in 1 BOTTLE (50090-1023-1) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-1023-25009010230215 TABLET in 1 BOTTLE (50090-1023-2) 15 tablet2021-10-150000-00-00NoNoCurrent