FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
68180-779
11-digit product format
681800779
Labeler code
68180
Product ID
68180-779_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
6.25 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 TARTRATE6.25 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
68180-779-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10022
68180-779-02ZOLPIDEM TARTRATE500 in 1 BOTTLETABLET, EXTENDED RELEASE50022
68180-779-03ZOLPIDEM TARTRATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100022
68180-779-04ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10022
68180-779-06ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE3022
68180-779-11ZOLPIDEM TARTRATE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-779-01EA - Each68180-779929cef35-eded-4af3-b405-d118a317baf112014-05-02
68180-779-04EA - Each68180-77903bf9093-0169-4a3f-90f9-8fa51b98151312024-06-10

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
68180-779ZOLPIDEM 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
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNbf99cd5c-9671-45a6-bda9-3dfc8252efdd104
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDbf99cd5c-9671-45a6-bda9-3dfc8252efdd104
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN028bf425-7a72-464d-a242-aa5deee1ac23100
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD028bf425-7a72-464d-a242-aa5deee1ac23100
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
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN76ff87e4-3aa2-439d-8436-d9e6affb33c82
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD76ff87e4-3aa2-439d-8436-d9e6affb33c82
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN30c057fb-2e1b-4b9c-8c8a-79c322151e611
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN1a8a8072-39bf-44c5-e063-6294a90a77c31
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN30c057fb-2e1b-4b9c-8c8a-79c322151e611
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD30c057fb-2e1b-4b9c-8c8a-79c322151e611
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD1a8a8072-39bf-44c5-e063-6294a90a77c31
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
68180-779-0168180077901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-01) 2014-04-110000-00-00NoNoCurrent
68180-779-0268180077902500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-02) 2014-04-110000-00-00NoNoCurrent
68180-779-03681800779031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-03) 2014-04-110000-00-00NoNoCurrent
68180-779-0468180077904100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-04) 2024-05-21NoNoHistorical
68180-779-066818007790630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-06) 2014-04-110000-00-00NoNoCurrent
68180-779-116818007791110 in 1 BLISTER PACKHistorical
68180-779-13681800779135 BLISTER PACK in 1 CARTON (68180-779-13) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68180-779-11) 5 blister pack2014-04-110000-00-00NoNoCurrent