FDA.reportPublic FDA data

Alprazolam

Product NDC
71335-2133
11-digit product format
713352133
Labeler code
71335
Product ID
71335-2133_8ea1648d-8205-4d5f-af0c-b77772d049db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074342
Marketing category
ANDA
Marketing start
1993-10-01
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
Rxcui308047

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
71335-2133-0Alprazolam10 in 1 BOTTLETABLET10103
71335-2133-1Alprazolam30 in 1 BOTTLETABLET30103
71335-2133-2Alprazolam100 in 1 BOTTLETABLET100103
71335-2133-3Alprazolam60 in 1 BOTTLETABLET60103
71335-2133-4Alprazolam20 in 1 BOTTLETABLET20103
71335-2133-5Alprazolam90 in 1 BOTTLETABLET90103
71335-2133-6Alprazolam15 in 1 BOTTLETABLET15103
71335-2133-7Alprazolam120 in 1 BOTTLETABLET120103
71335-2133-8Alprazolam40 in 1 BOTTLETABLET40103
71335-2133-9Alprazolam14 in 1 BOTTLETABLET14103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2133ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240526_8ca8e0fc-6c3d-48d4-ad04-708182b45350.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN8ca8e0fc-6c3d-48d4-ad04-708182b45350103
308047alprazolam 0.25 MG Oral TabletSCD8ca8e0fc-6c3d-48d4-ad04-708182b45350103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2133-07133521330010 TABLET in 1 BOTTLE (71335-2133-0) 10 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-17133521330130 TABLET in 1 BOTTLE (71335-2133-1) 30 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-271335213302100 TABLET in 1 BOTTLE (71335-2133-2) 100 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-37133521330360 TABLET in 1 BOTTLE (71335-2133-3) 60 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-47133521330420 TABLET in 1 BOTTLE (71335-2133-4) 20 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-57133521330590 TABLET in 1 BOTTLE (71335-2133-5) 90 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-67133521330615 TABLET in 1 BOTTLE (71335-2133-6) 15 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-771335213307120 TABLET in 1 BOTTLE (71335-2133-7) 120 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-87133521330840 TABLET in 1 BOTTLE (71335-2133-8) 40 tablet2022-07-270000-00-00NoNoCurrent
71335-2133-97133521330914 TABLET in 1 BOTTLE (71335-2133-9) 14 tablet2022-07-270000-00-00NoNoCurrent