FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
76420-263
11-digit product format
764200263
Labeler code
76420
Product ID
76420-263_2dc3187e-761a-9ef3-e063-6294a90ae216
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Substance
ZOLPIDEM TARTRATE
Active strength
10 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 TARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873, 854876

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
76420-263-00ZOLPIDEM TARTRATE1000 in 1 BOTTLETABLET10002
76420-263-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET1002
76420-263-05ZOLPIDEM TARTRATE500 in 1 BOTTLETABLET5002
76420-263-15ZOLPIDEM TARTRATE1500 in 1 BOTTLETABLET15002
76420-263-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET302
76420-263-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET602
76420-263-90ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-263-30EA - Each76420-2633c51cb92-fb38-42e4-8037-8666875ffd1812022-10-06
76420-263-60EA - Each76420-263ba078cff-32f5-428e-aba7-a293d0c05d1d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-263ZOLPIDEM TARTRATE TABLET [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 7 package rows20250212_e5e2d31b-ce26-78b0-e053-2a95a90ac491.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854876zolpidem tartrate 5 MG Oral TabletPSNe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854873zolpidem tartrate 10 MG Oral TabletSCDe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854876zolpidem tartrate 5 MG Oral TabletSCDe5e2d31b-ce26-78b0-e053-2a95a90ac4912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-263-00764200263001000 TABLET in 1 BOTTLE (76420-263-00) 1000 tablet2025-02-10NoNoHistorical
76420-263-0176420026301100 TABLET in 1 BOTTLE (76420-263-01) 100 tablet2025-02-10NoNoHistorical
76420-263-0576420026305500 TABLET in 1 BOTTLE (76420-263-05) 500 tablet2025-02-10NoNoHistorical
76420-263-15764200263151500 TABLET in 1 BOTTLE (76420-263-15) 1500 tablet2025-02-10NoNoHistorical
76420-263-307642002633030 TABLET in 1 BOTTLE (76420-263-30) 30 tablet2022-08-100000-00-00NoNoCurrent
76420-263-607642002636060 TABLET in 1 BOTTLE (76420-263-60) 60 tablet2022-08-100000-00-00NoNoCurrent
76420-263-907642002639090 TABLET in 1 BOTTLE (76420-263-90) 90 tablet2025-02-10NoNoHistorical