Alprazolam

Product NDC
53002-3950
11-digit product format
530023950
Labeler code
53002
Product ID
53002-3950_9ce63d54-65b7-45e6-bc26-5d1587d8c255
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA200739
Marketing category
ANDA
Marketing start
2015-10-01
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3950-1Alprazolam10 in 1 BOTTLETABLET104
53002-3950-2Alprazolam20 in 1 BOTTLETABLET204
53002-3950-3Alprazolam30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3950ALPRAZOLAM TABLET [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 3 package rows20201217_81e74e77-398a-45db-a8df-a59bee5c97ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN81e74e77-398a-45db-a8df-a59bee5c97ad4
308048alprazolam 0.5 MG Oral TabletSCD81e74e77-398a-45db-a8df-a59bee5c97ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3950-15300239500110 TABLET in 1 BOTTLE (53002-3950-1) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-3950-25300239500220 TABLET in 1 BOTTLE (53002-3950-2) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-3950-35300239500330 TABLET in 1 BOTTLE (53002-3950-3) 30 tablet2017-10-010000-00-00NoNoCurrent