FDA.reportPublic FDA data

Zolpidem tartrate

Product NDC
63629-4597
11-digit product format
636294597
Labeler code
63629
Product ID
63629-4597_56db3e80-5b7e-4611-92c7-88ed80f4e657
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
12.5 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
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 TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880

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
63629-4597-12024-09-10C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-22024-09-10C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-32024-09-10C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-42024-09-10C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-52024-09-10C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-62024-09-10C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-12024-01-30C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-22024-01-30C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-32024-01-30C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-42024-01-30C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-52024-01-30C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-62024-01-30C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-12022-02-16C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-22022-02-16C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-12019-11-27C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-22019-11-27C16284748780-19855d018-d445-cd31-e053-dbdaa90ab51aThese 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
63629-4597-1Zolpidem tartrate30 in 1 BOTTLETABLET, EXTENDED RELEASE301004
63629-4597-2Zolpidem tartrate60 in 1 BOTTLETABLET, EXTENDED RELEASE601004
63629-4597-3Zolpidem tartrate28 in 1 BOTTLETABLET, EXTENDED RELEASE281004
63629-4597-4Zolpidem tartrate8 in 1 BOTTLETABLET, EXTENDED RELEASE81004
63629-4597-5Zolpidem tartrate18 in 1 BOTTLETABLET, EXTENDED RELEASE181004
63629-4597-6Zolpidem tartrate90 in 1 BOTTLETABLET, EXTENDED RELEASE901004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4597-1EA - Each63629-4597b29a64e1-73b9-4736-86ce-0a7ddc6f187312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4597ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1004Current NDC, Legacy NDC, 6 package rows20240912_ce301d8b-0a8c-4404-8697-57222ae17a44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNce301d8b-0a8c-4404-8697-57222ae17a441004
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDce301d8b-0a8c-4404-8697-57222ae17a441004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4597-16362945970130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-1) 2012-08-290000-00-00NoNoCurrent
63629-4597-26362945970260 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-2) 2015-11-160000-00-00NoNoCurrent
63629-4597-36362945970328 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-3) 2024-09-050000-00-00NoNoCurrent
63629-4597-4636294597048 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-4) 2024-09-050000-00-00NoNoCurrent
63629-4597-56362945970518 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-5) 2024-09-050000-00-00NoNoCurrent
63629-4597-66362945970690 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-6) 2024-09-050000-00-00NoNoCurrent