FDA.reportPublic FDA data

ALPRAZOLAM

Product NDC
61919-005
11-digit product format
619190005
Labeler code
61919
Product ID
61919-005_f1ffc068-9963-5382-e053-2995a90a1cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA074112
Marketing category
ANDA
Marketing start
2014-01-01
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
2024-12-31
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
61919-005-302025-01-30C16284748780-12cef2736-a64c-d83d-e063-dadaa90ab31fALPRAZOLAM
61919-005-602025-01-30C16284748780-12cef2736-a64c-d83d-e063-dadaa90ab31fALPRAZOLAM
61919-005-902025-01-30C16284748780-12cef2736-a64c-d83d-e063-dadaa90ab31fALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-005-30ALPRAZOLAM30 in 1 BOTTLETABLET309
61919-005-60ALPRAZOLAM60 in 1 BOTTLETABLET609
61919-005-90ALPRAZOLAM90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-005-30EA - Each61919-0052dcf5f10-c1a6-4508-a576-974029e5985e12014-05-02
61919-005-60EA - Each61919-005b17da03b-e8a3-464d-bfc1-e4a4c022407c12015-05-05
61919-005-90EA - Each61919-005bb5ada88-553e-408c-be56-c4f1caa5aa7e12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]3
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [DIRECT RX]3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [DIRECT RX]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [DIRECT RX]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-005ALPRAZOLAM TABLET [DIRECT RX]9Legacy NDC, 3 package rows20230331_f420b7ad-a0ae-4936-b7eb-12d347af2ef3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSNf420b7ad-a0ae-4936-b7eb-12d347af2ef39
308048alprazolam 0.5 MG Oral TabletSCDf420b7ad-a0ae-4936-b7eb-12d347af2ef39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-005-306191900053030 TABLET in 1 BOTTLE (61919-005-30) 30 tablet2019-09-160000-00-00NoNoCurrent
61919-005-606191900056060 TABLET in 1 BOTTLE (61919-005-60) 60 tablet2019-09-160000-00-00NoNoCurrent
61919-005-906191900059090 TABLET in 1 BOTTLE (61919-005-90) 90 tablet2019-09-160000-00-00NoNoCurrent