ZOLPIDEM TARTRATE

Product NDC
0904-6082
11-digit product format
009046082
Labeler code
0904
Product ID
0904-6082_0f5acdac-482c-4150-b8e4-8488d4eee975
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
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
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 TARTRATE5 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
0904-6082-61ZOLPIDEM TARTRATE100 in 1 CARTONTABLET10019
0904-6082-61ZOLPIDEM TARTRATE1 in 1 BLISTER PACKTABLET119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6082-61EA - Each0904-608242e5f70d-7096-4d03-a2e6-036db1d065f912012-07-24

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
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6082ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]18Current NDC, Legacy 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
854876zolpidem tartrate 5 MG Oral TabletPSN83510333-f07d-4b81-a3ae-2801d114bd319
854876zolpidem tartrate 5 MG Oral TabletSCD83510333-f07d-4b81-a3ae-2801d114bd319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6082-6100904608261100 BLISTER PACK in 1 CARTON (0904-6082-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2007-09-050000-00-00NoNoCurrent