FDA.reportPublic FDA data

Alprazolam

Product NDC
71335-1669
11-digit product format
713351669
Labeler code
71335
Product ID
71335-1669_1a903918-4b82-41a8-89c1-2dfc56c1d423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090871
Marketing category
ANDA
Marketing start
2011-06-07
Substance
ALPRAZOLAM
Active strength
.5 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.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui433798

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
71335-1669-1Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE606
71335-1669-2Alprazolam30 in 1 BOTTLETABLET, EXTENDED RELEASE306
71335-1669-3Alprazolam90 in 1 BOTTLETABLET, EXTENDED RELEASE906
71335-1669-4Alprazolam45 in 1 BOTTLETABLET, EXTENDED RELEASE456
71335-1669-5Alprazolam120 in 1 BOTTLETABLET, EXTENDED RELEASE1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1669ALPRAZOLAM TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20231109_0dce8232-0b0e-4f81-af95-36e6febdb550.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN0dce8232-0b0e-4f81-af95-36e6febdb5506
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD0dce8232-0b0e-4f81-af95-36e6febdb5506
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY0dce8232-0b0e-4f81-af95-36e6febdb5506

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1669-17133516690160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-1) 2021-05-120000-00-00NoNoCurrent
71335-1669-27133516690230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-2) 2022-02-140000-00-00NoNoCurrent
71335-1669-37133516690390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-3) 2020-07-210000-00-00NoNoCurrent
71335-1669-47133516690445 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-4) 2022-02-140000-00-00NoNoCurrent
71335-1669-571335166905120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-5) 2022-02-14NoNoCurrent