Zolpidem Tartrate

Product NDC
50090-3994
11-digit product format
500903994
Labeler code
50090
Product ID
50090-3994_a51e0136-aff5-422a-92b3-e483038077b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078148
Marketing category
ANDA
Marketing start
2011-04-14
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3994-0Zolpidem TartrateExtended-Release20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3994ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190123_b7dd9153-61c4-463b-bab2-73c880a93643.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNb7dd9153-61c4-463b-bab2-73c880a936431
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDb7dd9153-61c4-463b-bab2-73c880a936431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3994-05009039940020 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-3994-0) 2018-12-180000-00-00NoNoCurrent