FDA.reportPublic FDA data

Alprazolam

Product NDC
45865-696
11-digit product format
458650696
Labeler code
45865
Product ID
45865-696_1b7f4459-15d9-1051-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA074342
Marketing category
ANDA
Marketing start
1995-01-03
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
2 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
45865-696-302020-01-31C16284748780-19d75b9d0-f748-f424-e053-dadaa90a57ceAlprazolam Tablets, USP
45865-696-602020-01-31C16284748780-19d75b9d0-f748-f424-e053-dadaa90a57ceAlprazolam Tablets, USP
45865-696-902020-01-31C16284748780-19d75b9d0-f748-f424-e053-dadaa90a57ceAlprazolam Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-696-30Alprazolam30 in 1 BOTTLETABLET302
45865-696-60Alprazolam60 in 1 BOTTLETABLET602
45865-696-90Alprazolam90 in 1 BOTTLETABLET902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-696ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 3 package rows20150723_1b7f4459-15d8-1051-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197322ALPRAZolam 2 MG Oral TabletPSN1b7f4459-15d8-1051-e054-00144ff8d46c2
197322alprazolam 2 MG Oral TabletSCD1b7f4459-15d8-1051-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-696-304586506963030 in 1 BOTTLEHistorical
45865-696-604586506966060 in 1 BOTTLEHistorical
45865-696-904586506969090 in 1 BOTTLEHistorical