FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
0781-5318
11-digit product format
007815318
Labeler code
0781
Product ID
0781-5318_d01ebe6c-e538-4039-8af6-cadae62f6989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA077322
Marketing category
ANDA
Marketing start
2007-04-23
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0781-5318-01Zolpidem Tartrate100 in 1 BOTTLETABLET, COATED10021
0781-5318-05Zolpidem Tartrate500 in 1 BOTTLETABLET, COATED50021
0781-5318-10Zolpidem Tartrate1000 in 1 BOTTLETABLET, COATED100021
0781-5318-31Zolpidem Tartrate30 in 1 BOTTLETABLET, COATED3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5318-01EA - Each0781-531817ce96d2-ac0d-482e-be9e-c49a8a7d8e9912013-02-13
0781-5318-10EA - Each0781-531883528983-3b30-4443-8a19-9b2ee4a370ce12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
POVIDONESINACTIVE INGREDIENTFZ989GH94EZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5318ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]21Current NDC, Legacy NDC, 4 package rows20250228_0553e26c-f2aa-43aa-adf9-6eb951a501d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN0553e26c-f2aa-43aa-adf9-6eb951a501d321
854876zolpidem tartrate 5 MG Oral TabletPSN0553e26c-f2aa-43aa-adf9-6eb951a501d321
854873zolpidem tartrate 10 MG Oral TabletSCD0553e26c-f2aa-43aa-adf9-6eb951a501d321
854876zolpidem tartrate 5 MG Oral TabletSCD0553e26c-f2aa-43aa-adf9-6eb951a501d321
854873zolpidem tartrate 10 MG Oral TabletPSNaf87b722-cdb7-0b17-e053-2a95a90a315b5
854873zolpidem tartrate 10 MG Oral TabletSCDaf87b722-cdb7-0b17-e053-2a95a90a315b5
854873zolpidem tartrate 10 MG Oral TabletPSN0f8488f3-851d-4111-af23-60f420aad0d64
854873zolpidem tartrate 10 MG Oral TabletPSN92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674
854876zolpidem tartrate 5 MG Oral TabletPSN92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674
854873zolpidem tartrate 10 MG Oral TabletSCD0f8488f3-851d-4111-af23-60f420aad0d64
854873zolpidem tartrate 10 MG Oral TabletSCD92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674
854876zolpidem tartrate 5 MG Oral TabletSCD92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674
854873zolpidem tartrate 10 MG Oral TabletPSN47212207-52a1-938b-e063-6294a90abca82
854873zolpidem tartrate 10 MG Oral TabletSCD47212207-52a1-938b-e063-6294a90abca82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5318-0100781531801100 TABLET, COATED in 1 BOTTLE (0781-5318-01) 2007-04-230000-00-00NoNoCurrent
0781-5318-0500781531805500 TABLET, COATED in 1 BOTTLE (0781-5318-05) 2007-04-230000-00-00NoNoCurrent
0781-5318-10007815318101000 TABLET, COATED in 1 BOTTLE (0781-5318-10) 2007-04-230000-00-00NoNoCurrent
0781-5318-310078153183130 TABLET, COATED in 1 BOTTLE (0781-5318-31) 2007-04-230000-00-00NoNoCurrent