ALPRAZOLAM

Product NDC
52959-964
11-digit product format
529590964
Labeler code
52959
Product ID
52959-964_79619e0f-1603-40ea-e053-2a91aa0a2700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA090871
Marketing category
ANDA
Marketing start
2015-12-14
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
2020-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
YU55MQ3IZYALPRAZOLAM28981-97-7ALPRAZOLAM

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52959-964-305295909643030 TABLET, EXTENDED RELEASE in 1 BOTTLE (52959-964-30) 2015-12-140000-00-00NoNoCurrent
52959-964-605295909646060 TABLET, EXTENDED RELEASE in 1 BOTTLE (52959-964-60) 2015-12-140000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
0964 ALPRAZOLAM ERH.J. Harkins Company, Inc.2018-10-24HUMAN PRESCRIPTION DRUG LABEL1