FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
51407-942
11-digit product format
514070942
Labeler code
51407
Product ID
51407-942_509ba752-e8a7-b190-e063-6294a90a5794
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077214
Marketing category
ANDA
Marketing start
2007-04-23
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE10 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
51407-942-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, FILM COATED1002
51407-942-10ZOLPIDEM TARTRATE1000 in 1 BOTTLETABLET, FILM COATED10002
51407-942-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-942-01EA - Each51407-942cf3f555d-b010-431c-a585-5f2da03bef5412025-02-10
51407-942-10EA - Each51407-942ec86d0d8-3b24-4c4f-8dc2-c39a2855507f12025-02-10
51407-942-30EA - Each51407-9425459f785-4f77-4b5d-a5f9-83d331c831ba12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-942ZOLPIDEM TARTRATE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 3 package rows20250112_2b5cf535-ccdc-ecd7-e063-6394a90a726e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN2b5cf535-ccdc-ecd7-e063-6394a90a726e2
854876zolpidem tartrate 5 MG Oral TabletPSN2b5cf535-ccdc-ecd7-e063-6394a90a726e2
854873zolpidem tartrate 10 MG Oral TabletSCD2b5cf535-ccdc-ecd7-e063-6394a90a726e2
854876zolpidem tartrate 5 MG Oral TabletSCD2b5cf535-ccdc-ecd7-e063-6394a90a726e2
854873zolpidem tartrate 10 MG Oral TabletPSN3882d72d-686b-406b-e063-6294a90a0b891
854873zolpidem tartrate 10 MG Oral TabletSCD3882d72d-686b-406b-e063-6294a90a0b891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-942-0151407094201100 TABLET, FILM COATED in 1 BOTTLE (51407-942-01) 2024-12-06NoNoCurrent
51407-942-10514070942101000 TABLET, FILM COATED in 1 BOTTLE (51407-942-10) 2024-12-06NoNoCurrent
51407-942-305140709423030 TABLET, FILM COATED in 1 BOTTLE (51407-942-30) 2024-12-06NoNoCurrent