FDA.reportPublic FDA data

Alprazolam

Product NDC
72789-313
11-digit product format
727890313
Labeler code
72789
Product ID
72789-313_40bb1fd8-e70f-47eb-e063-6394a90a74a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074342
Marketing category
ANDA
Marketing start
1993-10-01
Substance
ALPRAZOLAM
Active strength
.5 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.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
72789-313-06Alprazolam6 in 1 BOTTLE, PLASTICTABLET621
72789-313-30Alprazolam30 in 1 BOTTLE, PLASTICTABLET3021
72789-313-60Alprazolam60 in 1 BOTTLE, PLASTICTABLET6021
72789-313-90Alprazolam90 in 1 BOTTLE, PLASTICTABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-313-06EA - Each72789-31369bbb038-81bb-4514-b0fe-ba6022194e5212024-08-12
72789-313-30EA - Each72789-3136805b7ea-826d-42b4-be32-d00811eb758a12023-09-05
72789-313-60EA - Each72789-31396960442-ebd0-4b04-b46b-5872d4360d0512023-06-06
72789-313-90EA - Each72789-31325c9f1f6-b39e-4297-9fba-03f1711f7b7f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-313ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]20Current NDC, 4 package rows20240620_5040e1ed-32d6-4757-a0ee-b8240f3e7cf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN5040e1ed-32d6-4757-a0ee-b8240f3e7cf521
308048alprazolam 0.5 MG Oral TabletSCD5040e1ed-32d6-4757-a0ee-b8240f3e7cf521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-313-06727890313066 TABLET in 1 BOTTLE, PLASTIC (72789-313-06) 6 tablet2024-06-18NoNoCurrent
72789-313-307278903133030 TABLET in 1 BOTTLE, PLASTIC (72789-313-30) 30 tablet2023-07-31NoNoCurrent
72789-313-607278903136060 TABLET in 1 BOTTLE, PLASTIC (72789-313-60) 60 tablet2023-05-09NoNoCurrent
72789-313-907278903139090 TABLET in 1 BOTTLE, PLASTIC (72789-313-90) 90 tablet2023-03-16NoNoCurrent