FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
71335-1180
11-digit product format
713351180
Labeler code
71335
Product ID
71335-1180_c07ec814-9324-46cc-b19e-a75b438c2152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
71335-1180-1ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE30105
71335-1180-2ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE60105
71335-1180-3ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET, EXTENDED RELEASE28105
71335-1180-4ZOLPIDEM TARTRATE8 in 1 BOTTLETABLET, EXTENDED RELEASE8105
71335-1180-5ZOLPIDEM TARTRATE18 in 1 BOTTLETABLET, EXTENDED RELEASE18105
71335-1180-6ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET, EXTENDED RELEASE90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1180-1EA - Each71335-1180faac3d15-3db1-44d8-87a0-32fe3d14ff5912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1180ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 6 package rows20240830_604e77ef-2cda-4efc-abfb-9af549d40fd4.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1180-17133511800130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1180-1) 2019-04-040000-00-00NoNoCurrent
71335-1180-27133511800260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1180-2) 2024-07-090000-00-00NoNoCurrent
71335-1180-37133511800328 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1180-3) 2024-07-090000-00-00NoNoCurrent
71335-1180-4713351180048 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1180-4) 2024-07-090000-00-00NoNoCurrent
71335-1180-57133511800518 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1180-5) 2024-07-090000-00-00NoNoCurrent
71335-1180-67133511800690 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1180-6) 2024-07-090000-00-00NoNoCurrent