FDA.reportPublic FDA data

Alprazolam

Product NDC
71335-0849
11-digit product format
713350849
Labeler code
71335
Product ID
71335-0849_0c7b43c4-2e1e-48c3-a2ff-6af163b63dba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
71335-0849-02024-05-15C16284748780-11030e365-05ed-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
71335-0849-12024-05-15C16284748780-11030e365-05ed-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
71335-0849-22024-05-15C16284748780-11030e365-05ed-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
71335-0849-32024-05-15C16284748780-11030e365-05ed-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
71335-0849-42024-05-15C16284748780-11030e365-05ed-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
71335-0849-52024-05-15C16284748780-11030e365-05ed-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
71335-0849-62024-05-15C16284748780-11030e365-05ed-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
71335-0849-72024-05-15C16284748780-11030e365-05ed-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
71335-0849-82024-05-15C16284748780-11030e365-05ed-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
71335-0849-92024-05-15C16284748780-11030e365-05ed-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
71335-0849-02024-01-30C16284748780-11030e365-05ed-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
71335-0849-12024-01-30C16284748780-11030e365-05ed-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
71335-0849-22024-01-30C16284748780-11030e365-05ed-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
71335-0849-32024-01-30C16284748780-11030e365-05ed-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
71335-0849-42024-01-30C16284748780-11030e365-05ed-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
71335-0849-52024-01-30C16284748780-11030e365-05ed-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
71335-0849-62024-01-30C16284748780-11030e365-05ed-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
71335-0849-72024-01-30C16284748780-11030e365-05ed-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
71335-0849-82024-01-30C16284748780-11030e365-05ed-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
71335-0849-92024-01-30C16284748780-11030e365-05ed-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
71335-0849-0Alprazolam10 in 1 BOTTLETABLET106
71335-0849-1Alprazolam15 in 1 BOTTLETABLET156
71335-0849-2Alprazolam30 in 1 BOTTLETABLET306
71335-0849-3Alprazolam20 in 1 BOTTLETABLET206
71335-0849-4Alprazolam100 in 1 BOTTLETABLET1006
71335-0849-5Alprazolam90 in 1 BOTTLETABLET906
71335-0849-6Alprazolam60 in 1 BOTTLETABLET606
71335-0849-7Alprazolam120 in 1 BOTTLETABLET1206
71335-0849-8Alprazolam28 in 1 BOTTLETABLET286
71335-0849-9Alprazolam2 in 1 BOTTLETABLET26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0849-5EA - Each71335-08497845e349-087a-4f42-a831-3dba339dfb3712019-01-24
71335-0849-6EA - Each71335-0849742b8d75-3424-4fae-b66b-2aa1838738fb12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0849ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240517_25781f50-d309-4c4f-9e21-c019e068d101.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN25781f50-d309-4c4f-9e21-c019e068d1016
308048alprazolam 0.5 MG Oral TabletSCD25781f50-d309-4c4f-9e21-c019e068d1016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0849-07133508490010 TABLET in 1 BOTTLE (71335-0849-0) 10 tablet2022-05-020000-00-00NoNoCurrent
71335-0849-17133508490115 TABLET in 1 BOTTLE (71335-0849-1) 15 tablet2018-06-200000-00-00NoNoCurrent
71335-0849-27133508490230 TABLET in 1 BOTTLE (71335-0849-2) 30 tablet2018-06-080000-00-00NoNoCurrent
71335-0849-37133508490320 TABLET in 1 BOTTLE (71335-0849-3) 20 tablet2022-05-020000-00-00NoNoCurrent
71335-0849-471335084904100 TABLET in 1 BOTTLE (71335-0849-4) 100 tablet2022-05-020000-00-00NoNoCurrent
71335-0849-57133508490590 TABLET in 1 BOTTLE (71335-0849-5) 90 tablet2018-09-060000-00-00NoNoCurrent
71335-0849-67133508490660 TABLET in 1 BOTTLE (71335-0849-6) 60 tablet2018-06-080000-00-00NoNoCurrent
71335-0849-771335084907120 TABLET in 1 BOTTLE (71335-0849-7) 120 tablet2022-05-020000-00-00NoNoCurrent
71335-0849-87133508490828 TABLET in 1 BOTTLE (71335-0849-8) 28 tablet2022-05-020000-00-00NoNoCurrent
71335-0849-9713350849092 TABLET in 1 BOTTLE (71335-0849-9) 2 tablet2018-06-220000-00-00NoNoCurrent