FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
68788-7422
11-digit product format
687887422
Labeler code
68788
Product ID
68788-7422_863f54b1-8957-47f0-87cd-0f2472356b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred 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

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
68788-7422-2ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET, EXTENDED RELEASE288
68788-7422-3ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE308
68788-7422-6ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE608
68788-7422-9ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7422-2EA - Each68788-7422fcd1a84c-5535-4883-b650-517e30d2bdf212021-11-09
68788-7422-3EA - Each68788-7422a0e41311-44a6-4e97-9848-080b1052c6ec12021-11-09
68788-7422-6EA - Each68788-742283ccd7c8-0cdc-4503-ba99-eba457b3d36312021-11-09
68788-7422-9EA - Each68788-742201580d92-52e9-4d1d-9000-c5ec47fa293f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7422ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC..]7Current NDC, Legacy NDC, 4 package rows20240906_72e19b8e-d13a-4824-aee4-11778eba552c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7422-26878874220228 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7422-2) 2019-10-010000-00-00NoNoCurrent
68788-7422-36878874220330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7422-3) 2019-10-010000-00-00NoNoCurrent
68788-7422-66878874220660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7422-6) 2019-10-010000-00-00NoNoCurrent
68788-7422-96878874220990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7422-9) 2019-10-010000-00-00NoNoCurrent