Alprazolam

Product NDC
45865-424
11-digit product format
458650424
Labeler code
45865
Product ID
45865-424_1b66047b-478c-4808-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078491
Marketing category
ANDA
Marketing start
2008-09-25
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
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-424-30Alprazolam30 in 1 BOTTLE, PLASTICTABLET302
45865-424-60Alprazolam60 in 1 BOTTLE, PLASTICTABLET602

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
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM 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
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-424ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20150721_1b66a205-ad3f-0037-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN1b66a205-ad3f-0037-e054-00144ff88e882
308048alprazolam 0.5 MG Oral TabletSCD1b66a205-ad3f-0037-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-424-304586504243030 TABLET in 1 BOTTLE, PLASTIC (45865-424-30) 30 tablet2014-02-140000-00-00NoNoCurrent
45865-424-604586504246060 TABLET in 1 BOTTLE, PLASTIC (45865-424-60) 60 tablet2014-02-140000-00-00NoNoCurrent