FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
68071-2354
11-digit product format
680712354
Labeler code
68071
Product ID
68071-2354_4b3272fa-6308-bed3-e063-6394a90ac433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078970
Marketing category
ANDA
Marketing start
2014-04-11
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
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 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
68071-2354-92025-01-09C16284748780-1f386c64a-3f17-0266-e053-dadaa90a7c1aThese 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 CIV Initial U.S. Approval: 1992
68071-2354-92023-01-30C16284748780-1f386c64a-3f17-0266-e053-dadaa90a7c1aThese 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 CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2354-9ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2354ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20250112_bca751bb-5161-5a95-e053-2a95a90aa2dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNbca751bb-5161-5a95-e053-2a95a90aa2dd3
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDbca751bb-5161-5a95-e053-2a95a90aa2dd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2354-96807123540990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2354-9) 2021-03-030000-00-00NoNoCurrent