FDA.reportPublic FDA data

Alprazolam

Product NDC
50090-4950
11-digit product format
500904950
Labeler code
50090
Product ID
50090-4950_77850ef6-04db-4b47-8106-2ea149530073
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA018276
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1981-10-16
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
2022-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4950-02023-01-30C16284748780-1f386c649-d6ca-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV
50090-4950-12023-01-30C16284748780-1f386c649-d6ca-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV
50090-4950-22023-01-30C16284748780-1f386c649-d6ca-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV
50090-4950-32023-01-30C16284748780-1f386c649-d6ca-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4950-0Alprazolam30 in 1 BOTTLETABLET303
50090-4950-1Alprazolam20 in 1 BOTTLETABLET203
50090-4950-2Alprazolam60 in 1 BOTTLETABLET603
50090-4950-3Alprazolam90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4950ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 4 package rows20210615_fd860598-5dcc-4c66-aba5-43c1cd8202de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSNfd860598-5dcc-4c66-aba5-43c1cd8202de3
308048alprazolam 0.5 MG Oral TabletSCDfd860598-5dcc-4c66-aba5-43c1cd8202de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4950-05009049500030 TABLET in 1 BOTTLE (50090-4950-0) 30 tablet2020-03-030000-00-00NoNoCurrent
50090-4950-15009049500120 TABLET in 1 BOTTLE (50090-4950-1) 20 tablet2020-03-030000-00-00NoNoCurrent
50090-4950-25009049500260 TABLET in 1 BOTTLE (50090-4950-2) 60 tablet2020-03-020000-00-00NoNoCurrent
50090-4950-35009049500390 TABLET in 1 BOTTLE (50090-4950-3) 90 tablet2020-03-030000-00-00NoNoCurrent