FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
76420-319
11-digit product format
764200319
Labeler code
76420
Product ID
76420-319_327e6538-4b98-1f09-e063-6294a90a2f75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Asclemed USA, 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
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, 854894

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
76420-319-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
76420-319-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE301
76420-319-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE601
76420-319-90ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-319-01EA - Each76420-3196bf9a446-5fef-47e9-924b-12e338ff04fe12025-08-11
76420-319-30EA - Each76420-31986dd3062-2ee4-4ea3-ac69-a543e43787be12025-08-11
76420-319-60EA - Each76420-3197183ecee-4976-4f58-b8aa-436ad1aed98612025-08-11
76420-319-90EA - Each76420-31912888814-3057-40e3-b813-25b53f46bb5712025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-319ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [ASCLEMED USA, INC.]1Current NDC, 4 package rows20250413_30c057fb-2e1b-4b9c-8c8a-79c322151e61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN30c057fb-2e1b-4b9c-8c8a-79c322151e611
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN30c057fb-2e1b-4b9c-8c8a-79c322151e611
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD30c057fb-2e1b-4b9c-8c8a-79c322151e611
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD30c057fb-2e1b-4b9c-8c8a-79c322151e611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-319-0176420031901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-319-01) 2025-04-11NoNoHistorical
76420-319-307642003193030 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-319-30) 2025-04-11NoNoHistorical
76420-319-607642003196060 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-319-60) 2025-04-11NoNoHistorical
76420-319-907642003199090 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-319-90) 2025-04-11NoNoHistorical