FDA.reportPublic FDA data

ALPRAZOLAM

Product NDC
61919-006
11-digit product format
619190006
Labeler code
61919
Product ID
61919-006_b812a66c-dbb4-4d5b-b941-be5ecae914a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078491
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
E
Listing certified through
2017-12-31
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
61919-006-302020-01-31C16284748780-19d75b9d0-1b46-f424-e053-dadaa90a57ceALPRAZOLAM
61919-006-602020-01-31C16284748780-19d75b9d0-1b46-f424-e053-dadaa90a57ceALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-006-30ALPRAZOLAM30 in 1 BOTTLETABLET305
61919-006-60ALPRAZOLAM60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-006-30EA - Each61919-006f576272b-dd04-4839-9af6-9702b758bb9112015-10-02
61919-006-60EA - Each61919-006c729bc0d-36a2-46b0-b898-cc9d04bc9f5312016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]5
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [DIRECT RX]5
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [DIRECT RX]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALPRAZOLAM TABLET [DIRECT RX]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [DIRECT RX]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [DIRECT RX]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [DIRECT RX]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [DIRECT RX]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALPRAZOLAM TABLET [DIRECT RX]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-006ALPRAZOLAM TABLET [DIRECT RX]5Legacy NDC, 2 package rows20150630_843ee20e-7a49-4e5a-b826-ece7207adf92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197321ALPRAZolam 1 MG Oral TabletPSN843ee20e-7a49-4e5a-b826-ece7207adf925
197321alprazolam 1 MG Oral TabletSCD843ee20e-7a49-4e5a-b826-ece7207adf925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-006-306191900063030 in 1 BOTTLEHistorical
61919-006-606191900066060 in 1 BOTTLEHistorical