FDA.reportPublic FDA data

Alprazolam

Product NDC
71335-0920
11-digit product format
713350920
Labeler code
71335
Product ID
71335-0920_acde6be9-207c-4954-b94d-7c7777a9188e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074909
Marketing category
ANDA
Marketing start
1998-03-25
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
2 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
ALPRAZOLAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197322

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0920-12024-05-16C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-22024-05-16C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-32024-05-16C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-42024-05-16C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-52024-05-16C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-62024-05-16C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-72024-05-16C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-12024-01-30C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-22024-01-30C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-32024-01-30C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-42024-01-30C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-52024-01-30C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-62024-01-30C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
71335-0920-72024-01-30C16284748780-11030e365-479b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0920-1Alprazolam30 in 1 BOTTLETABLET309
71335-0920-2Alprazolam60 in 1 BOTTLETABLET609
71335-0920-3Alprazolam90 in 1 BOTTLETABLET909
71335-0920-4Alprazolam100 in 1 BOTTLETABLET1009
71335-0920-5Alprazolam10 in 1 BOTTLETABLET109
71335-0920-6Alprazolam120 in 1 BOTTLETABLET1209
71335-0920-7Alprazolam40 in 1 BOTTLETABLET409

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0920ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 7 package rows20240518_b0000772-2514-45a2-a75d-1bbb13c29989.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197322ALPRAZolam 2 MG Oral TabletPSNb0000772-2514-45a2-a75d-1bbb13c299899
197322alprazolam 2 MG Oral TabletSCDb0000772-2514-45a2-a75d-1bbb13c299899

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0920-17133509200130 TABLET in 1 BOTTLE (71335-0920-1) 30 tablet2018-08-022027-03-19NoNoCurrent
71335-0920-27133509200260 TABLET in 1 BOTTLE (71335-0920-2) 60 tablet2021-12-282027-03-19NoNoCurrent
71335-0920-37133509200390 TABLET in 1 BOTTLE (71335-0920-3) 90 tablet2021-12-282027-03-19NoNoCurrent
71335-0920-471335092004100 TABLET in 1 BOTTLE (71335-0920-4) 100 tablet2021-12-282027-03-19NoNoCurrent
71335-0920-57133509200510 TABLET in 1 BOTTLE (71335-0920-5) 10 tablet2021-12-282027-03-19NoNoCurrent
71335-0920-671335092006120 TABLET in 1 BOTTLE (71335-0920-6) 120 tablet2021-12-282027-03-19NoNoCurrent
71335-0920-77133509200740 TABLET in 1 BOTTLE (71335-0920-7) 40 tablet2021-12-282027-03-19NoNoCurrent