Alprazolam

Product NDC
63187-445
11-digit product format
631870445
Labeler code
63187
Product ID
63187-445_7522bce9-9d0b-4cf7-a57b-86301bbef471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090871
Marketing category
ANDA
Marketing start
2011-06-07
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
YU55MQ3IZYALPRAZOLAM28981-97-7ALPRAZOLAM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63187-445-306318704453030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-30) 2018-12-01NoNoHistorical
63187-445-606318704456060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-60) 2018-12-01NoNoHistorical
63187-445-906318704459090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-90) 2018-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Alprazolam Extended-Release Tablets USP CIV Rx onlyProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL3