FDA.reportPublic FDA data

Alprazolam

Product NDC
50090-2896
11-digit product format
500902896
Labeler code
50090
Product ID
50090-2896_71cb1809-575a-436e-be2f-2a457cd1a17d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074112
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321, 197322, 308047

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
50090-2896-1Alprazolam30 in 1 BOTTLETABLET3027
50090-2896-2Alprazolam60 in 1 BOTTLETABLET6027
50090-2896-3Alprazolam100 in 1 BOTTLETABLET10027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2896-1EA - Each50090-2896301e09a3-feb5-4af5-a2ed-0d3bbd4a447612019-04-11
50090-2896-2EA - Each50090-289603c9b71a-a2e5-4988-8758-0c27e8d9d29c12023-07-06
50090-2896-3EA - Each50090-28967243196d-77d3-4eac-9987-de79a6e39e3512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2896ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 3 package rows20250516_3c0cb60f-1c3a-48a6-ad16-f14351548412.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
197321ALPRAZolam 1 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
197322ALPRAZolam 2 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
308047alprazolam 0.25 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227
197321alprazolam 1 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227
197322alprazolam 2 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2896-15009028960130 TABLET in 1 BOTTLE (50090-2896-1) 30 tablet2017-03-012027-03-19NoNoHistorical
50090-2896-25009028960260 TABLET in 1 BOTTLE (50090-2896-2) 60 tablet2023-06-072027-03-19NoNoHistorical
50090-2896-350090289603100 TABLET in 1 BOTTLE (50090-2896-3) 100 tablet2023-06-072027-03-19NoNoHistorical