FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
50090-1022
11-digit product format
500901022
Labeler code
50090
Product ID
50090-1022_cf926dab-fe3a-481a-a836-d6d950be8ea8
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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1022-02023-02-07C16284748780-1f386c649-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
50090-1022-02023-02-07C16284748780-1f386c649-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
50090-1022-12023-02-07C16284748780-1f386c649-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
50090-1022-12023-02-07C16284748780-1f386c649-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
50090-1022-22023-02-07C16284748780-1f386c649-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
50090-1022-22023-02-07C16284748780-1f386c649-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
50090-1022-32023-02-07C16284748780-1f386c649-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
50090-1022-32023-02-07C16284748780-1f386c649-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
50090-1022-42023-02-07C16284748780-1f386c649-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
50090-1022-42023-02-07C16284748780-1f386c649-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
50090-1022-02023-01-30C16284748780-1f386c649-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
50090-1022-02023-01-30C16284748780-1f386c649-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
50090-1022-12023-01-30C16284748780-1f386c649-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
50090-1022-12023-01-30C16284748780-1f386c649-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
50090-1022-22023-01-30C16284748780-1f386c649-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
50090-1022-22023-01-30C16284748780-1f386c649-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
50090-1022-32023-01-30C16284748780-1f386c649-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
50090-1022-32023-01-30C16284748780-1f386c649-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
50090-1022-42023-01-30C16284748780-1f386c649-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
50090-1022-42023-01-30C16284748780-1f386c649-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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1022-0ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET2033
50090-1022-1ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET3033
50090-1022-2ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET1033
50090-1022-3ZOLPIDEM TARTRATE3 in 1 BOTTLETABLET333
50090-1022-4ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET6033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1022-0EA - Each50090-1022d8489230-b025-4626-a3a1-598ec9eac48712018-10-11
50090-1022-1EA - Each50090-1022cca77165-f69d-487e-82ce-daf6cd27977d12018-10-11
50090-1022-2EA - Each50090-1022713e44fc-be28-42c9-a0e2-3ab4cd66082b12018-10-11
50090-1022-3EA - Each50090-102271657fde-1997-4c04-8b26-aac91df6c1e112018-10-11
50090-1022-4EA - Each50090-10228987f9fc-8e49-40f7-a1ba-64b602f129d012022-12-07

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
50090-1022ZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS]28Current NDC, Legacy NDC, 5 package rows20250516_59cc61da-838e-4add-b2d6-42b2b283a000.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN59cc61da-838e-4add-b2d6-42b2b283a00033
854876zolpidem tartrate 5 MG Oral TabletSCD59cc61da-838e-4add-b2d6-42b2b283a00033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1022-05009010220020 TABLET in 1 BOTTLE (50090-1022-0) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-1022-15009010220130 TABLET in 1 BOTTLE (50090-1022-1) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-1022-25009010220210 TABLET in 1 BOTTLE (50090-1022-2) 10 tablet2014-11-280000-00-00NoNoCurrent
50090-1022-3500901022033 TABLET in 1 BOTTLE (50090-1022-3) 3 tablet2014-11-280000-00-00NoNoCurrent
50090-1022-45009010220460 TABLET in 1 BOTTLE (50090-1022-4) 60 tablet2018-12-070000-00-00NoNoCurrent