FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
43353-242
11-digit product format
433530242
Labeler code
43353
Product ID
43353-242_4ed996d1-66be-44cf-bbec-4a75fb121157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
5 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
2020-12-31
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
43353-242-102023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-142023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-152023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-202023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-282023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-302023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-452023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-532023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-592023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
43353-242-602023-01-30C16284748780-1f386c649-fc8f-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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-242-10ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET103
43353-242-14ZOLPIDEM TARTRATE14 in 1 BOTTLETABLET143
43353-242-15ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET153
43353-242-20ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET203
43353-242-28ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET283
43353-242-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET303
43353-242-45ZOLPIDEM TARTRATE45 in 1 BOTTLETABLET453
43353-242-53ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET603
43353-242-59ZOLPIDEM TARTRATE22 in 1 BOTTLETABLET223
43353-242-60ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-242-10EA - Each43353-2423d508abf-4587-4ead-81f2-638364751d7112017-11-06
43353-242-14EA - Each43353-2425938c793-d46f-4275-9afe-ec01ec5f22b512017-11-06
43353-242-15EA - Each43353-2428cd31598-3e7d-4c2d-bb0b-4ac0e7c4438012017-11-06
43353-242-20EA - Each43353-2428c47b6b8-162d-41dd-a487-61bb35c9b8b412017-11-06
43353-242-28EA - Each43353-2425c0eaeee-0a11-485b-976b-5681a1e16abc12017-11-06
43353-242-30EA - Each43353-24246f18d05-a574-42af-b0b9-9961e03f2a4f12017-11-06
43353-242-45EA - Each43353-242c8cf88aa-89a4-4c73-92b9-f72233a05c2c12017-11-06
43353-242-53EA - Each43353-2422d6c2e2b-556f-4a66-a0eb-dd6824e437a212017-11-06
43353-242-59EA - Each43353-24226aa5099-43ef-4934-8247-eefb04952a8c12017-11-06
43353-242-60EA - Each43353-2426367365f-f3d9-46bb-a0ba-2ffc06a807d612017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-242ZOLPIDEM TARTRATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 10 package rows20200101_c0543e05-3220-4a8a-abd9-6a73c42848c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNc0543e05-3220-4a8a-abd9-6a73c42848c23
854876zolpidem tartrate 5 MG Oral TabletPSNc0543e05-3220-4a8a-abd9-6a73c42848c23
854873zolpidem tartrate 10 MG Oral TabletSCDc0543e05-3220-4a8a-abd9-6a73c42848c23
854876zolpidem tartrate 5 MG Oral TabletSCDc0543e05-3220-4a8a-abd9-6a73c42848c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-242-104335302421010 TABLET in 1 BOTTLE (43353-242-10) 10 tablet2016-10-060000-00-00NoNoCurrent
43353-242-144335302421414 TABLET in 1 BOTTLE (43353-242-14) 14 tablet2016-10-060000-00-00NoNoCurrent
43353-242-154335302421515 TABLET in 1 BOTTLE (43353-242-15) 15 tablet2016-10-060000-00-00NoNoCurrent
43353-242-204335302422020 TABLET in 1 BOTTLE (43353-242-20) 20 tablet2016-10-060000-00-00NoNoCurrent
43353-242-284335302422828 TABLET in 1 BOTTLE (43353-242-28) 28 tablet2016-10-060000-00-00NoNoCurrent
43353-242-304335302423030 TABLET in 1 BOTTLE (43353-242-30) 30 tablet2016-10-060000-00-00NoNoCurrent
43353-242-454335302424545 TABLET in 1 BOTTLE (43353-242-45) 45 tablet2016-10-060000-00-00NoNoCurrent
43353-242-534335302425360 TABLET in 1 BOTTLE (43353-242-53) 60 tablet2016-10-060000-00-00NoNoCurrent
43353-242-594335302425922 TABLET in 1 BOTTLE (43353-242-59) 22 tablet2016-10-060000-00-00NoNoCurrent
43353-242-604335302426090 TABLET in 1 BOTTLE (43353-242-60) 90 tablet2016-10-060000-00-00NoNoCurrent