Alprazolam

Product NDC
80425-0284
11-digit product format
804250284
Labeler code
80425
Product ID
80425-0284_2a9b9724-0255-e829-e063-6394a90a1c07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA074112
Marketing category
ANDA
Marketing start
2023-03-08
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
YU55MQ3IZYALPRAZOLAM28981-97-7ALPRAZOLAM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0284-18042502840130 TABLET in 1 BOTTLE (80425-0284-1) 30 tablet2023-03-082027-03-19NoNoHistorical
80425-0284-28042502840260 TABLET in 1 BOTTLE (80425-0284-2) 60 tablet2023-03-082027-03-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Alprazolam TabletsAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL2