FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
47335-307
11-digit product format
473350307
Labeler code
47335
Product ID
47335-307_4a5c474b-e752-4d01-be37-a66e7c9bf62e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA204170
Marketing category
ANDA
Marketing start
2017-05-15
Substance
ZOLPIDEM TARTRATE
Active strength
6.25 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 TARTRATE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880, 854894

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
47335-307-13Zolpidem Tartrate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50013
47335-307-88Zolpidem Tartrate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-307-88EA - Each47335-3078dd02ec5-9da4-4dd6-b23f-07cfeaeabbde12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-307ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 2 package rows20231026_0c64bc71-2e7f-4b15-a8e1-acb8de04395f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN0c64bc71-2e7f-4b15-a8e1-acb8de04395f13
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN0c64bc71-2e7f-4b15-a8e1-acb8de04395f13
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD0c64bc71-2e7f-4b15-a8e1-acb8de04395f13
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD0c64bc71-2e7f-4b15-a8e1-acb8de04395f13
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNa1faca42-6e46-4586-97ac-050b724e7d2a1
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDa1faca42-6e46-4586-97ac-050b724e7d2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-307-1347335030713500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-13) 2017-05-150000-00-00NoNoCurrent
47335-307-8847335030788100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-88) 2017-05-150000-00-00NoNoCurrent