FDA.reportPublic FDA data

Alprazolam

Product NDC
68788-8410
11-digit product format
687888410
Labeler code
68788
Product ID
68788-8410_c54362f6-d432-4173-b337-fb10ec165363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203346
Marketing category
ANDA
Marketing start
2023-03-22
Substance
ALPRAZOLAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui308048

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
68788-8410-3Alprazolam30 in 1 BOTTLETABLET304
68788-8410-6Alprazolam60 in 1 BOTTLETABLET604
68788-8410-9Alprazolam90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8410-3EA - Each68788-8410ac98593c-53ea-4d77-97f9-4f0bf7ffe14012023-06-06
68788-8410-6EA - Each68788-841019174e41-16c6-4d04-88a4-30d35548157612023-06-06
68788-8410-9EA - Each68788-8410481d5881-e93d-4c8e-a32f-4b53e29c1fb912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8410ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 3 package rows20250119_73c1d1dc-ade2-4bb4-b109-83bd63acd15c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN73c1d1dc-ade2-4bb4-b109-83bd63acd15c4
308048alprazolam 0.5 MG Oral TabletSCD73c1d1dc-ade2-4bb4-b109-83bd63acd15c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8410-36878884100330 TABLET in 1 BOTTLE (68788-8410-3) 30 tablet2023-03-22NoNoHistorical
68788-8410-66878884100660 TABLET in 1 BOTTLE (68788-8410-6) 60 tablet2023-03-22NoNoHistorical
68788-8410-96878884100990 TABLET in 1 BOTTLE (68788-8410-9) 90 tablet2023-03-22NoNoHistorical