Alprazolam

Product NDC
53002-3952
11-digit product format
530023952
Labeler code
53002
Product ID
53002-3952_204b18e7-8297-4436-b073-d74435c47922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074112
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
YU55MQ3IZYALPRAZOLAM28981-97-7ALPRAZOLAM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3952-15300239520110 TABLET in 1 BOTTLE (53002-3952-1) 10 tablet2021-01-010000-00-00NoNoCurrent
53002-3952-25300239520220 TABLET in 1 BOTTLE (53002-3952-2) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-3952-35300239520330 TABLET in 1 BOTTLE (53002-3952-3) 30 tablet2021-01-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AlprazolamRPK Pharmaceuticals, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL1