FDA.reportPublic FDA data

Alprazolam

Product NDC
50090-5078
11-digit product format
500905078
Labeler code
50090
Product ID
50090-5078_f8c1781d-12d5-43a2-a215-01ceced386d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074342
Marketing category
ANDA
Marketing start
1993-10-01
Substance
ALPRAZOLAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui308048

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
50090-5078-02023-02-06C16284748780-1f386c64a-3a58-0266-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
50090-5078-32023-02-06C16284748780-1f386c64a-3a58-0266-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
50090-5078-02023-01-30C16284748780-1f386c64a-3a58-0266-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
50090-5078-32023-01-30C16284748780-1f386c64a-3a58-0266-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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5078-0Alprazolam30 in 1 BOTTLETABLET3012
50090-5078-1Alprazolam20 in 1 BOTTLETABLET2012
50090-5078-2Alprazolam60 in 1 BOTTLETABLET6012
50090-5078-3Alprazolam90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5078-0EA - Each50090-5078515d41d7-d69b-41e2-a154-0fc62e484d9912023-10-16
50090-5078-1EA - Each50090-5078d2bb0a9f-8b08-45e8-a87b-8a62ec11549612023-10-16
50090-5078-2EA - Each50090-50786eb50e30-0e1e-4fe0-ae6f-905b18b889f312023-10-16
50090-5078-3EA - Each50090-5078d9dab991-7047-41d7-8dd8-975a9973cb2b12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5078ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 4 package rows20230921_8ef75d22-4a7c-48d5-a532-5a43b8593e7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN8ef75d22-4a7c-48d5-a532-5a43b8593e7c12
308048alprazolam 0.5 MG Oral TabletSCD8ef75d22-4a7c-48d5-a532-5a43b8593e7c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5078-05009050780030 TABLET in 1 BOTTLE (50090-5078-0) 30 tablet2020-06-170000-00-00NoNoCurrent
50090-5078-15009050780120 in 1 BOTTLEHistorical
50090-5078-25009050780260 TABLET in 1 BOTTLE (50090-5078-2) 60 tablet2023-09-18NoNoHistorical
50090-5078-35009050780390 TABLET in 1 BOTTLE (50090-5078-3) 90 tablet2020-06-170000-00-00NoNoCurrent