FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
63187-862
11-digit product format
631870862
Labeler code
63187
Product ID
63187-862_16ffd293-15a1-4014-9b06-6772decd7651
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021774
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-12-06
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
63187-862-15Zolpidem Tartrate15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE153
63187-862-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
63187-862-60Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
63187-862-90Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-862-30EA - Each63187-862aa97079a-da52-44e5-b52d-635fb2e45c7a12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-862ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20191113_facfc337-3447-4052-a9aa-8aa55282a3e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNfacfc337-3447-4052-a9aa-8aa55282a3e33
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDfacfc337-3447-4052-a9aa-8aa55282a3e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-862-156318708621515 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-15) 2017-06-010000-00-00NoNoCurrent
63187-862-306318708623030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-30) 2017-06-010000-00-00NoNoCurrent
63187-862-606318708626060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-60) 2017-06-010000-00-00NoNoCurrent
63187-862-906318708629090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-90) 2017-06-010000-00-00NoNoCurrent