ZOLPIDEM TARTRATE

Product NDC
0904-6083
11-digit product format
009046083
Labeler code
0904
Product ID
0904-6083_ddbe4e76-539b-4e28-b9a3-502a5728a435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
0904-6083-61ZOLPIDEM TARTRATE100 in 1 CARTONTABLET10019
0904-6083-61ZOLPIDEM TARTRATE1 in 1 BLISTER PACKTABLET119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6083-61EA - Each0904-608329cb4201-6c4d-4131-8365-be099503a0b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6083ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]18Legacy NDC, 2 package rows20250227_d34336b1-7041-4078-beda-94bc9d9f771e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNd34336b1-7041-4078-beda-94bc9d9f771e19
854876zolpidem tartrate 5 MG Oral TabletPSNd34336b1-7041-4078-beda-94bc9d9f771e19
854873zolpidem tartrate 10 MG Oral TabletSCDd34336b1-7041-4078-beda-94bc9d9f771e19
854876zolpidem tartrate 5 MG Oral TabletSCDd34336b1-7041-4078-beda-94bc9d9f771e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6083-6100904608361100 BLISTER PACK in 1 CARTON (0904-6083-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2007-09-050000-00-00NoNoCurrent