FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
50090-2649
11-digit product format
500902649
Labeler code
50090
Product ID
50090-2649_b75ac94e-cbd4-40de-97df-db9eeae46947
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
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 TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854876

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
50090-2649-0Zolpidem Tartrate20 in 1 BOTTLETABLET, FILM COATED2014
50090-2649-1Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED3014
50090-2649-2Zolpidem Tartrate10 in 1 BOTTLETABLET, FILM COATED1014
50090-2649-3Zolpidem Tartrate3 in 1 BOTTLETABLET, FILM COATED314
50090-2649-4Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2649-0EA - Each50090-2649d46adcb4-07d1-43bb-9019-770cfec37c7812019-04-11
50090-2649-1EA - Each50090-2649a3f0a86d-26cf-4999-92b1-19e2c7aadf1212019-04-11
50090-2649-2EA - Each50090-26492b2a14f8-ba0c-48fc-9a19-5ed3a2e46c1112019-04-11
50090-2649-3EA - Each50090-2649176f0811-1a58-4a62-b9f8-feb822c39e6212019-04-11
50090-2649-4EA - Each50090-2649f4d19c2b-9013-4e35-971d-ba4d49db2f3c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2649ZOLPIDEM TARTRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 5 package rows20241122_f67ef513-1b2c-42fe-bf33-4c7e9db191a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSNf67ef513-1b2c-42fe-bf33-4c7e9db191a314
854876zolpidem tartrate 5 MG Oral TabletSCDf67ef513-1b2c-42fe-bf33-4c7e9db191a314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-2649-05009026490020 TABLET, FILM COATED in 1 BOTTLE (50090-2649-0) 2016-12-20NoNoHistorical
50090-2649-15009026490130 TABLET, FILM COATED in 1 BOTTLE (50090-2649-1) 2017-01-17NoNoHistorical
50090-2649-25009026490210 in 1 BOTTLEHistorical
50090-2649-3500902649033 TABLET, FILM COATED in 1 BOTTLE (50090-2649-3) 2016-11-28NoNoHistorical
50090-2649-45009026490460 TABLET, FILM COATED in 1 BOTTLE (50090-2649-4) 2024-11-15NoNoHistorical