Alprazolam

Product NDC
63187-444
11-digit product format
631870444
Labeler code
63187
Product ID
63187-444_525278ca-7947-41ac-92cf-b5a4e90dc56c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074909
Marketing category
ANDA
Marketing start
1998-03-25
Substance
ALPRAZOLAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321, 197322, 308048

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-444-30Alprazolam30 in 1 BOTTLETABLET306
63187-444-60Alprazolam60 in 1 BOTTLETABLET606
63187-444-90Alprazolam90 in 1 BOTTLETABLET906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PROFICIENT RX LP]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PROFICIENT RX LP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-444ALPRAZOLAM TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20200818_717ce509-f92e-4ec1-a3c6-aeae54d56f4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197321ALPRAZolam 1 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197322ALPRAZolam 2 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
308048alprazolam 0.5 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197321alprazolam 1 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197322alprazolam 2 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-444-306318704443030 TABLET in 1 BOTTLE (63187-444-30) 30 tablet2014-03-030000-00-00NoNoCurrent
63187-444-606318704446060 TABLET in 1 BOTTLE (63187-444-60) 60 tablet2014-03-030000-00-00NoNoCurrent
63187-444-906318704449090 TABLET in 1 BOTTLE (63187-444-90) 90 tablet2014-03-030000-00-00NoNoCurrent