FDA.reportPublic FDA data

Alprazolam

Product NDC
71335-1839
11-digit product format
713351839
Labeler code
71335
Product ID
71335-1839_80de418c-0bed-4636-a72c-53747ab6add5
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
1 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
ALPRAZOLAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui433800

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
71335-1839-1Alprazolam30 in 1 BOTTLETABLET, EXTENDED RELEASE30104
71335-1839-2Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE60104
71335-1839-3Alprazolam90 in 1 BOTTLETABLET, EXTENDED RELEASE90104
71335-1839-4Alprazolam28 in 1 BOTTLETABLET, EXTENDED RELEASE28104
71335-1839-5Alprazolam120 in 1 BOTTLETABLET, EXTENDED RELEASE120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1839-1EA - Each71335-1839cc08cf3a-3736-42a2-bf97-14526f04a9a012023-09-05
71335-1839-2EA - Each71335-183996ad20ae-c539-4066-9c30-0d454768fdf012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1839ALPRAZOLAM TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20231128_aaab422d-c763-4352-8ffc-5aafdf91e8dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSNaaab422d-c763-4352-8ffc-5aafdf91e8dd104
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCDaaab422d-c763-4352-8ffc-5aafdf91e8dd104
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSYaaab422d-c763-4352-8ffc-5aafdf91e8dd104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1839-17133518390130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1839-1) 2021-04-200000-00-00NoNoCurrent
71335-1839-27133518390260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1839-2) 2022-03-100000-00-00NoNoCurrent
71335-1839-37133518390390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1839-3) 2022-03-100000-00-00NoNoCurrent
71335-1839-47133518390428 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1839-4) 2022-03-100000-00-00NoNoCurrent
71335-1839-571335183905120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1839-5) 2022-03-10NoNoCurrent