FDA.reportPublic FDA data

Alprazolam

Product NDC
87063-172
11-digit product format
870630172
Labeler code
87063
Product ID
87063-172_50a7293f-d49a-aff7-e063-6294a90a4c19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
ANDA203346
Marketing category
ANDA
Marketing start
2015-07-31
Substance
ALPRAZOLAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321, 197322, 308047, 308048

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0bProduct name120140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797Product name120140508
d153678e-a3c8-bad8-cfe0-385656dde0e7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87063-172-01Alprazolam100 in 1 BOTTLETABLET1001
87063-172-30Alprazolam30 in 1 BOTTLETABLET301
87063-172-60Alprazolam60 in 1 BOTTLETABLET601
87063-172-90Alprazolam90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048ALPRAZolam 0.5 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321ALPRAZolam 1 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197322ALPRAZolam 2 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047alprazolam 0.25 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048alprazolam 0.5 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321alprazolam 1 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197322alprazolam 2 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-172-0187063017201100 TABLET in 1 BOTTLE (87063-172-01) 100 tablet2026-04-30NoNoHistorical
87063-172-308706301723030 TABLET in 1 BOTTLE (87063-172-30) 30 tablet2026-04-30NoNoHistorical
87063-172-608706301726060 TABLET in 1 BOTTLE (87063-172-60) 60 tablet2026-04-30NoNoHistorical
87063-172-908706301729090 TABLET in 1 BOTTLE (87063-172-90) 90 tablet2026-04-30NoNoHistorical