FDA.reportPublic FDA data

Alprazolam

Product NDC
55289-523
11-digit product format
552890523
Labeler code
55289
Product ID
55289-523_2abee2c1-1fa5-af2e-e063-6294a90a6afb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074909
Marketing category
ANDA
Marketing start
1998-03-25
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197322

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
55289-523-01Alprazolam100 in 1 BOTTLE, PLASTICTABLET10021
55289-523-30Alprazolam30 in 1 BOTTLE, PLASTICTABLET3021
55289-523-40Alprazolam40 in 1 BOTTLE, PLASTICTABLET4021
55289-523-60Alprazolam60 in 1 BOTTLE, PLASTICTABLET6021
55289-523-90Alprazolam90 in 1 BOTTLE, PLASTICTABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-523-01EA - Each55289-523a6a9e43d-dd05-443c-ae7a-7f9b8f6488cf12012-07-24
55289-523-30EA - Each55289-5231456efc2-3e46-4759-adf5-3bec8922ddb412012-07-24
55289-523-40EA - Each55289-523f3dc5f8e-3cb3-4eb5-a85f-4a4822b5745012012-07-24
55289-523-60EA - Each55289-52397094945-fcd8-451b-bdbd-29a7a80ad69012012-07-24
55289-523-90EA - Each55289-5238a8e9e47-0f9b-4bc2-afd1-cf5b46f095ff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]2
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-523ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 5 package rows20250105_7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197322ALPRAZolam 2 MG Oral TabletPSN7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed321
197322alprazolam 2 MG Oral TabletSCD7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-523-0155289052301100 TABLET in 1 BOTTLE, PLASTIC (55289-523-01) 100 tablet2016-03-042027-03-19NoNoCurrent
55289-523-305528905233030 TABLET in 1 BOTTLE, PLASTIC (55289-523-30) 30 tablet2016-03-042027-03-19NoNoCurrent
55289-523-405528905234040 TABLET in 1 BOTTLE, PLASTIC (55289-523-40) 40 tablet2016-03-042027-03-19NoNoCurrent
55289-523-605528905236060 TABLET in 1 BOTTLE, PLASTIC (55289-523-60) 60 tablet2016-03-042027-03-19NoNoCurrent
55289-523-905528905239090 TABLET in 1 BOTTLE, PLASTIC (55289-523-90) 90 tablet2016-03-042027-03-19NoNoCurrent