FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
71335-1468
11-digit product format
713351468
Labeler code
71335
Product ID
71335-1468_8fc3132f-7766-4459-8ad9-bfc7e998f9bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204170
Marketing category
ANDA
Marketing start
2017-05-15
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
71335-1468-1Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
71335-1468-2Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE605
71335-1468-3Zolpidem Tartrate28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE285
71335-1468-4Zolpidem Tartrate8 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE85
71335-1468-5Zolpidem Tartrate18 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE185
71335-1468-6Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1468-1EA - Each71335-1468626d949c-4512-43b2-8fa8-05bde17ed03512022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1468ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 6 package rows20231109_90201886-86a5-4c59-a4f1-98270d620731.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN90201886-86a5-4c59-a4f1-98270d6207315
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD90201886-86a5-4c59-a4f1-98270d6207315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1468-17133514680130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-1) 2020-01-090000-00-00NoNoCurrent
71335-1468-27133514680260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-2) 2022-05-120000-00-00NoNoCurrent
71335-1468-37133514680328 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-3) 2022-05-120000-00-00NoNoCurrent
71335-1468-4713351468048 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-4) 2022-05-120000-00-00NoNoCurrent
71335-1468-57133514680518 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-5) 2022-05-120000-00-00NoNoCurrent
71335-1468-67133514680690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-6) 2020-10-120000-00-00NoNoCurrent