FDA.reportPublic FDA data

Alprazolam

Product NDC
67544-414
11-digit product format
675440414
Labeler code
67544
Product ID
67544-414_51152b89-539c-4c80-bb84-d7f2dc082953
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA018276
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1981-10-16
Substance
ALPRAZOLAM
Active strength
.25 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
ALPRAZOLAM.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321, 308047, 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
67544-414-15Alprazolam15 in 1 BOTTLETABLET151
67544-414-30Alprazolam30 in 1 BOTTLETABLET301
67544-414-45Alprazolam45 in 1 BOTTLETABLET451
67544-414-53Alprazolam60 in 1 BOTTLETABLET601
67544-414-60Alprazolam90 in 1 BOTTLETABLET901
67544-414-70Alprazolam120 in 1 BOTTLETABLET1201
67544-414-80Alprazolam180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-414-15EA - Each67544-414be6013ee-7954-4137-8a50-e1ae620c33b312018-02-20
67544-414-30EA - Each67544-4140106b30b-fc1d-4f76-998a-e75b0852124112023-12-05
67544-414-45EA - Each67544-414d23bbd9d-3b1e-4043-9ae2-e24fbfc2b9e212018-08-13
67544-414-53EA - Each67544-4140618c727-35a7-4c11-9d6d-602849b5d03f12023-12-05
67544-414-60EA - Each67544-414eb18c343-375c-4ba7-abb4-9c2bd84210ec12023-12-05
67544-414-70EA - Each67544-414996423da-1cfd-4cba-a20b-8f9bd392dfbe12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-414ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 7 package rows20180208_964d7f43-34a6-45af-a95f-3b9ade17c6a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN964d7f43-34a6-45af-a95f-3b9ade17c6a51
308048ALPRAZolam 0.5 MG Oral TabletPSN964d7f43-34a6-45af-a95f-3b9ade17c6a51
197321ALPRAZolam 1 MG Oral TabletPSN964d7f43-34a6-45af-a95f-3b9ade17c6a51
308047alprazolam 0.25 MG Oral TabletSCD964d7f43-34a6-45af-a95f-3b9ade17c6a51
308048alprazolam 0.5 MG Oral TabletSCD964d7f43-34a6-45af-a95f-3b9ade17c6a51
197321alprazolam 1 MG Oral TabletSCD964d7f43-34a6-45af-a95f-3b9ade17c6a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-414-156754404141515 TABLET in 1 BOTTLE (67544-414-15) 15 tablet2006-06-160000-00-00NoNoCurrent
67544-414-306754404143030 TABLET in 1 BOTTLE (67544-414-30) 30 tablet2005-06-300000-00-00NoNoCurrent
67544-414-456754404144545 TABLET in 1 BOTTLE (67544-414-45) 45 tablet2006-06-010000-00-00NoNoCurrent
67544-414-536754404145360 TABLET in 1 BOTTLE (67544-414-53) 60 tablet2005-06-300000-00-00NoNoCurrent
67544-414-606754404146090 TABLET in 1 BOTTLE (67544-414-60) 90 tablet2005-06-230000-00-00NoNoCurrent
67544-414-7067544041470120 TABLET in 1 BOTTLE (67544-414-70) 120 tablet2005-09-070000-00-00NoNoCurrent
67544-414-8067544041480180 TABLET in 1 BOTTLE (67544-414-80) 180 tablet2008-02-220000-00-00NoNoCurrent