FDA.reportPublic FDA data

Zolpidem

Product NDC
50436-0009
11-digit product format
504360009
Labeler code
50436
Product ID
50436-0009_2cb7ecc0-7d4c-487f-bc74-43e912ca4283
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
50436-0009-12024-01-30C16284748780-11030e365-659d-111a-e063-dadaa90a10e2These 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
50436-0009-22024-01-30C16284748780-11030e365-659d-111a-e063-dadaa90a10e2These 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
50436-0009-1Zolpidem30 in 1 BOTTLETABLET302
50436-0009-2Zolpidem60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0009-1EA - Each50436-00091016d991-f004-4381-b385-ae6cf8642a1212022-07-06
50436-0009-2EA - Each50436-0009b04933e4-c5ac-4a61-8b78-0ad32576762612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0009ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20220524_63f44ce5-de02-4d22-92b7-352059fda43b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN63f44ce5-de02-4d22-92b7-352059fda43b2
854876zolpidem tartrate 5 MG Oral TabletSCD63f44ce5-de02-4d22-92b7-352059fda43b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0009-15043600090130 TABLET in 1 BOTTLE (50436-0009-1) 30 tablet2022-03-010000-00-00NoNoCurrent
50436-0009-25043600090260 TABLET in 1 BOTTLE (50436-0009-2) 60 tablet2022-03-010000-00-00NoNoCurrent