FDA.reportPublic FDA data

Zolpidem tartrate

Product NDC
0781-5316
11-digit product format
007815316
Labeler code
0781
Product ID
0781-5316_0751e4b8-384e-4336-9e51-02d6b07a7777
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA090107
Marketing category
ANDA
Marketing start
2011-10-31
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 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 TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880, 854894

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
0781-5316-01Zolpidem tartrate100 in 1 BOTTLETABLET, EXTENDED RELEASE10016
0781-5316-05Zolpidem tartrate500 in 1 BOTTLETABLET, EXTENDED RELEASE50016
0781-5316-31Zolpidem tartrate30 in 1 BOTTLETABLET, EXTENDED RELEASE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5316-01EA - Each0781-5316ffbf977b-6c6a-4aee-ba4b-36d702d1b7a612012-07-24
0781-5316-05EA - Each0781-5316d7c998bf-9ef3-4a46-aa59-0790a0eb10c212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]7
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]4
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5316ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [SANDOZ INC]16Current NDC, Legacy NDC, 3 package rows20250228_b1b0085f-d9fe-430a-9bd5-607f607bf7e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNce301d8b-0a8c-4404-8697-57222ae17a441004
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDce301d8b-0a8c-4404-8697-57222ae17a441004
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNb1b0085f-d9fe-430a-9bd5-607f607bf7e116
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNb1b0085f-d9fe-430a-9bd5-607f607bf7e116
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDb1b0085f-d9fe-430a-9bd5-607f607bf7e116
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDb1b0085f-d9fe-430a-9bd5-607f607bf7e116
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN84db101f-3194-4a40-83e3-403df03dffe14
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD84db101f-3194-4a40-83e3-403df03dffe14
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN25e71199-c55d-4cc6-8388-b309d654d2b03
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD25e71199-c55d-4cc6-8388-b309d654d2b03
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN9addc6af-dffc-0942-e053-2a95a90ac9971
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD9addc6af-dffc-0942-e053-2a95a90ac9971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5316-0100781531601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5316-01) 2011-10-310000-00-00NoNoCurrent
0781-5316-0500781531605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5316-05) 2011-10-310000-00-00NoNoCurrent
0781-5316-310078153163130 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5316-31) 2011-10-310000-00-00NoNoCurrent