FDA.reportPublic FDA data

Alprazolam

Product NDC
67544-415
11-digit product format
675440415
Labeler code
67544
Product ID
67544-415_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
.5 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.5 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
67544-415-15Alprazolam15 in 1 BOTTLETABLET151
67544-415-20Alprazolam20 in 1 BOTTLETABLET201
67544-415-30Alprazolam30 in 1 BOTTLETABLET301
67544-415-45Alprazolam45 in 1 BOTTLETABLET451
67544-415-53Alprazolam60 in 1 BOTTLETABLET601
67544-415-55Alprazolam75 in 1 BOTTLETABLET751
67544-415-60Alprazolam90 in 1 BOTTLETABLET901
67544-415-70Alprazolam120 in 1 BOTTLETABLET1201
67544-415-75Alprazolam150 in 1 BOTTLETABLET1501
67544-415-80Alprazolam180 in 1 BOTTLETABLET1801
67544-415-92Alprazolam270 in 1 BOTTLETABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-415-15EA - Each67544-415ce631a68-8539-4081-9ec6-1bd3442e962f12018-02-20
67544-415-20EA - Each67544-415e63a51b3-72e4-4a7e-a0ce-0727e9edc48112018-02-20
67544-415-30EA - Each67544-415f86c73ca-031b-4043-af6f-d5f3cafa101812018-02-20
67544-415-45EA - Each67544-415dad80e43-2ae8-45d4-ac4b-5eea5378ed9312018-02-20
67544-415-53EA - Each67544-4158da02dd3-0d8f-4a4d-9a5c-c2d251f3d34112018-02-20
67544-415-60EA - Each67544-415b8209c35-1cdb-46ce-b008-4e8134c2187812018-02-20
67544-415-70EA - Each67544-41553a77da6-09db-4c4a-80a8-25094c2f40d912018-02-20
67544-415-75EA - Each67544-415c6d93425-af2e-4eda-a943-97b71a25e5af12018-02-20
67544-415-80EA - Each67544-41595de8455-a7bf-45f5-927d-0015a6ed371a12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-415ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 11 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
67544-415-156754404151515 TABLET in 1 BOTTLE (67544-415-15) 15 tablet2006-05-100000-00-00NoNoCurrent
67544-415-206754404152020 TABLET in 1 BOTTLE (67544-415-20) 20 tablet2010-04-260000-00-00NoNoCurrent
67544-415-306754404153030 TABLET in 1 BOTTLE (67544-415-30) 30 tablet2005-06-230000-00-00NoNoCurrent
67544-415-456754404154545 TABLET in 1 BOTTLE (67544-415-45) 45 tablet2006-05-250000-00-00NoNoCurrent
67544-415-536754404155360 TABLET in 1 BOTTLE (67544-415-53) 60 tablet2005-06-230000-00-00NoNoCurrent
67544-415-556754404155575 TABLET in 1 BOTTLE (67544-415-55) 75 tablet2010-04-260000-00-00NoNoCurrent
67544-415-606754404156090 TABLET in 1 BOTTLE (67544-415-60) 90 tablet2005-06-230000-00-00NoNoCurrent
67544-415-7067544041570120 TABLET in 1 BOTTLE (67544-415-70) 120 tablet2005-09-140000-00-00NoNoCurrent
67544-415-7567544041575150 TABLET in 1 BOTTLE (67544-415-75) 150 tablet2006-06-080000-00-00NoNoCurrent
67544-415-8067544041580180 TABLET in 1 BOTTLE (67544-415-80) 180 tablet2006-05-110000-00-00NoNoCurrent
67544-415-9267544041592270 TABLET in 1 BOTTLE (67544-415-92) 270 tablet2010-04-260000-00-00NoNoCurrent