FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
71205-286
11-digit product format
712050286
Labeler code
71205
Product ID
71205-286_bde02c60-5382-4505-b806-ddb2f5f9deab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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 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
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
71205-286-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-286-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-286-90ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-286-30EA - Each71205-2866333f24c-f2bf-4df7-8c52-25fd2beb2fba12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-286ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221116_acf9f431-3013-4cfd-ba4d-c4013f20bdab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNacf9f431-3013-4cfd-ba4d-c4013f20bdab2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDacf9f431-3013-4cfd-ba4d-c4013f20bdab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-286-307120502863030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-30) 2019-06-210000-00-00NoNoCurrent
71205-286-607120502866060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-60) 2019-06-210000-00-00NoNoCurrent
71205-286-907120502869090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-90) 2019-06-210000-00-00NoNoCurrent