FDA.reportPublic FDA data

Alprazolam

Product NDC
68788-8414
11-digit product format
687888414
Labeler code
68788
Product ID
68788-8414_e96542e1-2fba-4050-b0f4-98e8516705b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203346
Marketing category
ANDA
Marketing start
2023-04-07
Substance
ALPRAZOLAM
Active strength
.25 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.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
68788-8414-2Alprazolam20 in 1 BOTTLETABLET204
68788-8414-3Alprazolam30 in 1 BOTTLETABLET304
68788-8414-6Alprazolam60 in 1 BOTTLETABLET604
68788-8414-9Alprazolam90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8414-2EA - Each68788-841434af690a-1ee7-44b3-9bd7-41f88e78427b12023-06-06
68788-8414-3EA - Each68788-8414f8b82575-25ea-42cb-a581-2f43f6bbe5ec12023-06-06
68788-8414-6EA - Each68788-8414e0a7557b-9087-4eee-96e4-11433d1ef9e912023-06-06
68788-8414-9EA - Each68788-8414938dc352-e979-43e7-8616-43e3dd850d3712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8414ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250119_78682252-e448-4b20-b49d-27c2c70e4cb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN78682252-e448-4b20-b49d-27c2c70e4cb34
308047alprazolam 0.25 MG Oral TabletSCD78682252-e448-4b20-b49d-27c2c70e4cb34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8414-26878884140220 TABLET in 1 BOTTLE (68788-8414-2) 20 tablet2023-04-07NoNoCurrent
68788-8414-36878884140330 TABLET in 1 BOTTLE (68788-8414-3) 30 tablet2023-04-07NoNoCurrent
68788-8414-66878884140660 TABLET in 1 BOTTLE (68788-8414-6) 60 tablet2023-04-07NoNoCurrent
68788-8414-96878884140990 TABLET in 1 BOTTLE (68788-8414-9) 90 tablet2023-04-07NoNoCurrent