FDA.reportPublic FDA data

Alprazolam

Product NDC
50090-1759
11-digit product format
500901759
Labeler code
50090
Product ID
50090-1759_d5e0249a-0d5c-4703-8f8f-b082328da573
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074174
Marketing category
ANDA
Marketing start
2007-03-28
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
50090-1759-02023-01-30C16284748780-1f386c64a-2c31-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV Rx only
50090-1759-12023-01-30C16284748780-1f386c64a-2c31-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV Rx only
50090-1759-22023-01-30C16284748780-1f386c64a-2c31-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV Rx only
50090-1759-32023-01-30C16284748780-1f386c64a-2c31-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1759-0Alprazolam30 in 1 BOTTLETABLET3021
50090-1759-1Alprazolam20 in 1 BOTTLETABLET2021
50090-1759-2Alprazolam60 in 1 BOTTLETABLET6021
50090-1759-3Alprazolam90 in 1 BOTTLETABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1759-0EA - Each50090-1759c7efe3ac-8e49-40cc-b8a3-06396ba022f512018-10-11
50090-1759-1EA - Each50090-17593b3386fe-73c3-4a40-a9ba-8a494cc383c112018-09-05
50090-1759-2EA - Each50090-1759d9c1e57f-68e2-4cd2-a3b6-9e555625626912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1759ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]21Legacy NDC, 4 package rows20210226_cb179805-0e57-4902-82ed-bcfeb6b64528.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSNcb179805-0e57-4902-82ed-bcfeb6b6452821
308048alprazolam 0.5 MG Oral TabletSCDcb179805-0e57-4902-82ed-bcfeb6b6452821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1759-05009017590030 TABLET in 1 BOTTLE (50090-1759-0) 30 tablet2015-03-260000-00-00NoNoCurrent
50090-1759-15009017590120 TABLET in 1 BOTTLE (50090-1759-1) 20 tablet2015-03-260000-00-00NoNoCurrent
50090-1759-25009017590260 TABLET in 1 BOTTLE (50090-1759-2) 60 tablet2015-03-260000-00-00NoNoCurrent
50090-1759-35009017590390 TABLET in 1 BOTTLE (50090-1759-3) 90 tablet2015-03-260000-00-00NoNoCurrent