Alprazolam

Product NDC
80425-0444
11-digit product format
804250444
Labeler code
80425
Product ID
80425-0444_26f8b6d9-81c1-a02c-e063-6394a90aefdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA203346
Marketing category
ANDA
Marketing start
2024-11-06
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
80425-0444-1Alprazolam30 in 1 BOTTLETABLET301
80425-0444-2Alprazolam60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0444-1EA - Each80425-044491cc92fa-a093-46fd-b537-69aa511c2f7b12024-12-10
80425-0444-2EA - Each80425-044416e59241-cf31-4fcb-a588-171a33d20f0412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0444ALPRAZOLAM TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 2 package rows20241116_26f8b63c-6dad-8fac-e063-6394a90a5435.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197321ALPRAZolam 1 MG Oral TabletPSN26f8b63c-6dad-8fac-e063-6394a90a54351
197321alprazolam 1 MG Oral TabletSCD26f8b63c-6dad-8fac-e063-6394a90a54351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0444-18042504440130 TABLET in 1 BOTTLE (80425-0444-1) 30 tablet2024-11-06NoNoHistorical
80425-0444-28042504440260 TABLET in 1 BOTTLE (80425-0444-2) 60 tablet2024-11-06NoNoHistorical