FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
76420-416
11-digit product format
764200416
Labeler code
76420
Product ID
76420-416_3aa8cb56-eaef-625f-e063-6394a90a52ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
Substance
ZOLPIDEM TARTRATE
Active strength
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 TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873, 854876

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
76420-416-00Zolpidem Tartrate1000 in 1 BOTTLETABLET, FILM COATED10001
76420-416-01Zolpidem Tartrate100 in 1 BOTTLETABLET, FILM COATED1001
76420-416-05Zolpidem Tartrate500 in 1 BOTTLETABLET, FILM COATED5001
76420-416-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED301
76420-416-60Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED601
76420-416-90Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN9922ce14-b418-4235-9c59-d674a8e702101
854876zolpidem tartrate 5 MG Oral TabletPSN9922ce14-b418-4235-9c59-d674a8e702101
854873zolpidem tartrate 10 MG Oral TabletSCD9922ce14-b418-4235-9c59-d674a8e702101
854876zolpidem tartrate 5 MG Oral TabletSCD9922ce14-b418-4235-9c59-d674a8e702101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-416-00764200416001000 TABLET, FILM COATED in 1 BOTTLE (76420-416-00) 2025-07-24NoNoHistorical
76420-416-0176420041601100 TABLET, FILM COATED in 1 BOTTLE (76420-416-01) 2025-07-24NoNoHistorical
76420-416-0576420041605500 TABLET, FILM COATED in 1 BOTTLE (76420-416-05) 2025-07-24NoNoHistorical
76420-416-307642004163030 TABLET, FILM COATED in 1 BOTTLE (76420-416-30) 2025-07-24NoNoHistorical
76420-416-607642004166060 TABLET, FILM COATED in 1 BOTTLE (76420-416-60) 2025-07-24NoNoHistorical
76420-416-907642004169090 TABLET, FILM COATED in 1 BOTTLE (76420-416-90) 2025-07-24NoNoHistorical