FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
71335-2085
11-digit product format
713352085
Labeler code
71335
Product ID
71335-2085_82e22548-d84e-42c5-8837-719c5b5608a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078970
Marketing category
ANDA
Marketing start
2014-04-11
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2085-1ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET, EXTENDED RELEASE28104
71335-2085-2ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE30104
71335-2085-3ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE60104
71335-2085-4ZOLPIDEM TARTRATE8 in 1 BOTTLETABLET, EXTENDED RELEASE8104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2085-2EA - Each71335-20858d62794d-47fc-4fb6-8dce-563a658fb98412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2085ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20250402_bf99cd5c-9671-45a6-bda9-3dfc8252efdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNbf99cd5c-9671-45a6-bda9-3dfc8252efdd104
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDbf99cd5c-9671-45a6-bda9-3dfc8252efdd104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2085-17133520850128 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2085-1) 2024-07-150000-00-00NoNoCurrent
71335-2085-27133520850230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2085-2) 2022-05-040000-00-00NoNoCurrent
71335-2085-37133520850360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2085-3) 2024-07-150000-00-00NoNoCurrent
71335-2085-4713352085048 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2085-4) 2024-07-150000-00-00NoNoCurrent