ALPRAZOLAM

Product NDC
61919-576
11-digit product format
619190576
Labeler code
61919
Product ID
61919-576_9c591e3e-8c9e-b0c4-e053-2995a90aea13
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
0 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-576-602023-01-30C16284748780-1f386c649-d8df-0266-e053-dadaa90a7c1aALPRAZOLAM
61919-576-902023-01-30C16284748780-1f386c649-d8df-0266-e053-dadaa90a7c1aALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-576-60ALPRAZOLAM60 in 1 BOTTLETABLET603
61919-576-90ALPRAZOLAM90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-576-60EA - Each61919-57619e0aed4-a6b2-4979-88c4-2f9a1b30b43d12016-09-02
61919-576-90EA - Each61919-576a7113de1-5ab4-478e-8a5d-2f32079c32a512016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [DIRECT RX]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-576ALPRAZOLAM TABLET [DIRECT RX]3Legacy NDC, 2 package rows20200118_97d4c3ba-77f2-4a0f-9bc1-688290dde567.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN97d4c3ba-77f2-4a0f-9bc1-688290dde5673
308047alprazolam 0.25 MG Oral TabletSCD97d4c3ba-77f2-4a0f-9bc1-688290dde5673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-576-606191905766060 TABLET in 1 BOTTLE (61919-576-60) 60 tablet2015-01-010000-00-00NoNoCurrent
61919-576-906191905769090 TABLET in 1 BOTTLE (61919-576-90) 90 tablet2015-01-010000-00-00NoNoCurrent