FDA.reportPublic FDA data

Alprazolam

Product NDC
82804-027
11-digit product format
828040027
Labeler code
82804
Product ID
82804-027_60c90b4b-174f-4fd2-b65f-fc166c16bdc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA018276
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1981-10-16
Substance
ALPRAZOLAM
Active strength
.25 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.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
82804-027-30Alprazolam30 in 1 BOTTLETABLET301
82804-027-60Alprazolam60 in 1 BOTTLETABLET601
82804-027-90Alprazolam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-027-30EA - Each82804-027b488ac39-e2cc-4bf1-be86-6fc08112328a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-027ALPRAZOLAM TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20231027_60c90b4b-174f-4fd2-b65f-fc166c16bdc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN60c90b4b-174f-4fd2-b65f-fc166c16bdc11
308047alprazolam 0.25 MG Oral TabletSCD60c90b4b-174f-4fd2-b65f-fc166c16bdc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-027-308280400273030 TABLET in 1 BOTTLE (82804-027-30) 30 tablet2023-10-23NoNoCurrent
82804-027-608280400276060 TABLET in 1 BOTTLE (82804-027-60) 60 tablet2023-10-23NoNoCurrent
82804-027-908280400279090 TABLET in 1 BOTTLE (82804-027-90) 90 tablet2023-10-23NoNoCurrent