FDA.reportPublic FDA data

Alprazolam

Product NDC
53002-4181
11-digit product format
530024181
Labeler code
53002
Product ID
53002-4181_e2b02185-56bc-44ae-bdd9-a026ea688bf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA207507
Marketing category
ANDA
Marketing start
2018-07-09
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
0 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
53002-4181-12025-01-30C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-22025-01-30C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-32025-01-30C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-12023-06-08C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-22023-06-08C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-32023-06-08C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-12023-01-30C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-22023-01-30C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-32023-01-30C16284748780-1f386c64a-0dc6-0266-e053-dadaa90a7c1aThese 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
53002-4181-1Alprazolam10 in 1 BOTTLETABLET103
53002-4181-2Alprazolam20 in 1 BOTTLETABLET203
53002-4181-3Alprazolam30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4181ALPRAZOLAM TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_7454d713-9332-4acd-ad1f-84379fca87c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN7454d713-9332-4acd-ad1f-84379fca87c43
308047alprazolam 0.25 MG Oral TabletSCD7454d713-9332-4acd-ad1f-84379fca87c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4181-15300241810110 TABLET in 1 BOTTLE (53002-4181-1) 10 tablet2020-01-010000-00-00NoNoCurrent
53002-4181-25300241810220 TABLET in 1 BOTTLE (53002-4181-2) 20 tablet2020-01-010000-00-00NoNoCurrent
53002-4181-35300241810330 TABLET in 1 BOTTLE (53002-4181-3) 30 tablet2020-01-010000-00-00NoNoCurrent