FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
68180-780
11-digit product format
681800780
Labeler code
68180
Product ID
68180-780_e56668d7-16c2-4618-ba3b-df3853f307e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078970
Marketing category
ANDA
Marketing start
2014-04-11
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
68180-780-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10022
68180-780-02ZOLPIDEM TARTRATE500 in 1 BOTTLETABLET, EXTENDED RELEASE50022
68180-780-03ZOLPIDEM TARTRATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100022
68180-780-04ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10022
68180-780-06ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE3022
68180-780-11ZOLPIDEM TARTRATE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-780-01EA - Each68180-7804030af0d-cdfc-4c37-886d-bbaaa96de43712014-05-02
68180-780-04EA - Each68180-780387907ae-61c1-499b-a3ad-b3313d95204412024-06-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]5
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-780ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 6 package rows20250125_ac647afe-2fe5-4056-806f-abdd54789b45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN604e77ef-2cda-4efc-abfb-9af549d40fd4105
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD604e77ef-2cda-4efc-abfb-9af549d40fd4105
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNac647afe-2fe5-4056-806f-abdd54789b4522
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNac647afe-2fe5-4056-806f-abdd54789b4522
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDac647afe-2fe5-4056-806f-abdd54789b4522
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDac647afe-2fe5-4056-806f-abdd54789b4522
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN72e19b8e-d13a-4824-aee4-11778eba552c8
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD72e19b8e-d13a-4824-aee4-11778eba552c8
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNbca751bb-5161-5a95-e053-2a95a90aa2dd3
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDbca751bb-5161-5a95-e053-2a95a90aa2dd3
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN08411424-e8a8-4964-bd04-5b0b5aa5baaf2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNc3f23bc3-595b-28e5-e053-2a95a90a9c2c2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNacf9f431-3013-4cfd-ba4d-c4013f20bdab2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDc3f23bc3-595b-28e5-e053-2a95a90a9c2c2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDacf9f431-3013-4cfd-ba4d-c4013f20bdab2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD08411424-e8a8-4964-bd04-5b0b5aa5baaf2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN30c057fb-2e1b-4b9c-8c8a-79c322151e611
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNb96e0270-d3e0-4d24-b575-ec0c130fad2b1
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN21767f56-ce92-2b8c-e063-6394a90a8b761
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN30c057fb-2e1b-4b9c-8c8a-79c322151e611
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDb96e0270-d3e0-4d24-b575-ec0c130fad2b1
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD30c057fb-2e1b-4b9c-8c8a-79c322151e611
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD21767f56-ce92-2b8c-e063-6394a90a8b761
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD30c057fb-2e1b-4b9c-8c8a-79c322151e611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-780-0168180078001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-780-01) 2014-04-110000-00-00NoNoCurrent
68180-780-0268180078002500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-780-02) 2014-04-110000-00-00NoNoCurrent
68180-780-03681800780031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-780-03) 2014-04-110000-00-00NoNoCurrent
68180-780-0468180078004100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-780-04) 2024-05-21NoNoCurrent
68180-780-066818007800630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-780-06) 2014-04-110000-00-00NoNoCurrent
68180-780-116818007801110 in 1 BLISTER PACKHistorical
68180-780-13681800780135 BLISTER PACK in 1 CARTON (68180-780-13) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68180-780-11) 5 blister pack2014-04-110000-00-00NoNoCurrent