FDA.reportPublic FDA data

Zolpidem tartrate

Product NDC
63629-4708
11-digit product format
636294708
Labeler code
63629
Product ID
63629-4708_d35cc5d8-cb3a-44e0-8059-1a1ba0a05352
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090107
Marketing category
ANDA
Marketing start
2011-10-31
Substance
ZOLPIDEM TARTRATE
Active strength
6.25 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 TARTRATE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854894

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
63629-4708-12021-12-30C16284748780-19855e2a2-41f7-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM tartrate extended-release tablets, for oral use C-IV Initial U.S. Approval: 1992
63629-4708-22021-12-30C16284748780-19855e2a2-41f7-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM tartrate extended-release tablets, for oral use C-IV Initial U.S. Approval: 1992
63629-4708-32021-12-30C16284748780-19855e2a2-41f7-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM tartrate extended-release tablets, for oral use C-IV Initial U.S. Approval: 1992
63629-4708-12019-11-27C16284748780-19855e2a2-41f7-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM tartrate extended-release tablets, for oral use C-IV Initial U.S. Approval: 1992
63629-4708-22019-11-27C16284748780-19855e2a2-41f7-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM tartrate extended-release tablets, for oral use C-IV Initial U.S. Approval: 1992
63629-4708-32019-11-27C16284748780-19855e2a2-41f7-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM tartrate extended-release tablets, for oral use C-IV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4708-1Zolpidem tartrate28 in 1 BOTTLETABLET, EXTENDED RELEASE281006
63629-4708-2Zolpidem tartrate30 in 1 BOTTLETABLET, EXTENDED RELEASE301006
63629-4708-3Zolpidem tartrate60 in 1 BOTTLETABLET, EXTENDED RELEASE601006
63629-4708-4Zolpidem tartrate8 in 1 BOTTLETABLET, EXTENDED RELEASE81006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4708ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1006Current NDC, Legacy NDC, 4 package rows20241108_82bca7a0-021f-4e35-8b3f-6390eeb863a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN82bca7a0-021f-4e35-8b3f-6390eeb863a61006
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD82bca7a0-021f-4e35-8b3f-6390eeb863a61006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4708-16362947080128 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4708-1) 2012-04-170000-00-00NoNoCurrent
63629-4708-26362947080230 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4708-2) 2013-05-160000-00-00NoNoCurrent
63629-4708-36362947080360 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4708-3) 2016-01-070000-00-00NoNoCurrent
63629-4708-4636294708048 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4708-4) 2024-10-290000-00-00NoNoCurrent