FDA.reportPublic FDA data

Alprazolam

Product NDC
53002-3952
11-digit product format
530023952
Labeler code
53002
Product ID
53002-3952_204b18e7-8297-4436-b073-d74435c47922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074112
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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
53002-3952-12025-01-30C16284748780-12cef2736-884a-d83d-e063-dadaa90ab31fThese 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
53002-3952-22025-01-30C16284748780-12cef2736-884a-d83d-e063-dadaa90ab31fThese 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
53002-3952-32025-01-30C16284748780-12cef2736-884a-d83d-e063-dadaa90ab31fThese 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
53002-3952-1Alprazolam10 in 1 BOTTLETABLET101
53002-3952-2Alprazolam20 in 1 BOTTLETABLET201
53002-3952-3Alprazolam30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3952ALPRAZOLAM TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_6f4678b4-7e1e-4cc6-87b8-effd4f436ad1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN6f4678b4-7e1e-4cc6-87b8-effd4f436ad11
308048alprazolam 0.5 MG Oral TabletSCD6f4678b4-7e1e-4cc6-87b8-effd4f436ad11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3952-15300239520110 TABLET in 1 BOTTLE (53002-3952-1) 10 tablet2021-01-010000-00-00NoNoCurrent
53002-3952-25300239520220 TABLET in 1 BOTTLE (53002-3952-2) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-3952-35300239520330 TABLET in 1 BOTTLE (53002-3952-3) 30 tablet2021-01-010000-00-00NoNoCurrent