ZOLPIDEM TARTRATE

Product NDC
70518-2917
11-digit product format
705182917
Labeler code
70518
Product ID
70518-2917_4ab8be78-6584-7397-e063-6394a90a08db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2019-09-26
Substance
ZOLPIDEM TARTRATE
Active strength
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 TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854876

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
70518-2917-0ZOLPIDEM TARTRATE60 in 1 BOTTLE, PLASTICTABLET606
70518-2917-1ZOLPIDEM TARTRATE30 in 1 BOTTLE, PLASTICTABLET306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN2abdcf77-d3ed-42bc-acd9-545aab75d5676
854876zolpidem tartrate 5 MG Oral TabletSCD2abdcf77-d3ed-42bc-acd9-545aab75d5676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2917-07051829170060 TABLET in 1 BOTTLE, PLASTIC (70518-2917-0) 60 tablet2019-09-260000-00-00NoNoCurrent
70518-2917-17051829170130 TABLET in 1 BOTTLE, PLASTIC (70518-2917-1) 30 tablet2025-06-16NoNoHistorical