Alprazolam

Product NDC
50090-5258
11-digit product format
500905258
Labeler code
50090
Product ID
50090-5258_c5e046d4-f03c-4a62-ab10-a07219433b33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207507
Marketing category
ANDA
Marketing start
2018-07-09
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
50090-5258-02023-02-07C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
50090-5258-12023-02-07C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
50090-5258-22023-02-07C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
50090-5258-32023-02-07C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
50090-5258-02023-01-30C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
50090-5258-12023-01-30C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
50090-5258-22023-01-30C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
50090-5258-32023-01-30C16284748780-1f386c64a-0d06-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5258ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]14Legacy NDC20250406_e06b3bdd-ae21-4503-861e-11412bb7e7ea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5258-05009052580090 TABLET in 1 BOTTLE (50090-5258-0) 90 tablet2020-10-150000-00-00NoNoCurrent
50090-5258-15009052580130 TABLET in 1 BOTTLE (50090-5258-1) 30 tablet2020-10-150000-00-00NoNoCurrent
50090-5258-25009052580260 TABLET in 1 BOTTLE (50090-5258-2) 60 tablet2020-10-150000-00-00NoNoCurrent
50090-5258-350090525803100 TABLET in 1 BOTTLE (50090-5258-3) 100 tablet2020-10-150000-00-00NoNoCurrent