FDA.reportPublic FDA data

Alprazolam

Product NDC
67544-347
11-digit product format
675440347
Labeler code
67544
Product ID
67544-347_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
1 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
ALPRAZOLAM1 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
67544-347-15Alprazolam15 in 1 BOTTLETABLET151
67544-347-30Alprazolam30 in 1 BOTTLETABLET301
67544-347-45Alprazolam45 in 1 BOTTLETABLET451
67544-347-53Alprazolam60 in 1 BOTTLETABLET601
67544-347-60Alprazolam90 in 1 BOTTLETABLET901
67544-347-70Alprazolam120 in 1 BOTTLETABLET1201
67544-347-75Alprazolam150 in 1 BOTTLETABLET1501
67544-347-80Alprazolam180 in 1 BOTTLETABLET1801
67544-347-90Alprazolam240 in 1 BOTTLETABLET2401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-347-15EA - Each67544-34737bb7ddc-eb0f-441a-b7b7-49b3ecfca64612018-02-20
67544-347-30EA - Each67544-347ae1f47c1-b53d-43c8-bca1-5d657b9a25e712018-07-03
67544-347-45EA - Each67544-347e73d16d3-0c91-4b8b-b443-1909106be5e312018-07-03
67544-347-53EA - Each67544-3476929b65a-4c6b-4031-849c-1356368dc2b312018-07-03
67544-347-60EA - Each67544-3473cad136b-e0c2-4c46-b9de-6d7288a062cc12018-07-03
67544-347-70EA - Each67544-3475e099e26-07be-480f-b481-ec9a6274977212018-07-03
67544-347-75EA - Each67544-3472ebb10bf-d883-4d5e-97fd-cdb6f0326e1912018-04-19
67544-347-80EA - Each67544-3471d300790-4c62-4d6b-8426-380e7367f7be12018-03-08
67544-347-90EA - Each67544-3470cee8f58-cda9-40fc-830a-39d1a3b8ac0612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-347ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 9 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
67544-347-156754403471515 TABLET in 1 BOTTLE (67544-347-15) 15 tablet2006-06-220000-00-00NoNoCurrent
67544-347-306754403473030 TABLET in 1 BOTTLE (67544-347-30) 30 tablet2005-06-230000-00-00NoNoCurrent
67544-347-456754403474545 TABLET in 1 BOTTLE (67544-347-45) 45 tablet2006-07-130000-00-00NoNoCurrent
67544-347-536754403475360 TABLET in 1 BOTTLE (67544-347-53) 60 tablet2005-06-230000-00-00NoNoCurrent
67544-347-606754403476090 TABLET in 1 BOTTLE (67544-347-60) 90 tablet2005-09-200000-00-00NoNoCurrent
67544-347-7067544034770120 TABLET in 1 BOTTLE (67544-347-70) 120 tablet2005-11-020000-00-00NoNoCurrent
67544-347-7567544034775150 TABLET in 1 BOTTLE (67544-347-75) 150 tablet2006-07-200000-00-00NoNoCurrent
67544-347-8067544034780180 TABLET in 1 BOTTLE (67544-347-80) 180 tablet2006-06-010000-00-00NoNoCurrent
67544-347-9067544034790240 TABLET in 1 BOTTLE (67544-347-90) 240 tablet2006-06-010000-00-00NoNoCurrent