FDA.reportPublic FDA data

ALPRAZOLAM

Product NDC
52959-964
11-digit product format
529590964
Labeler code
52959
Product ID
52959-964_79619e0f-1603-40ea-e053-2a91aa0a2700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA090871
Marketing category
ANDA
Marketing start
2015-12-14
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
2020-12-31
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
52959-964-302022-01-28C16284748780-1d6a99b39-b8a5-a426-e053-dadaa90af4c20964 ALPRAZOLAM ER
52959-964-602022-01-28C16284748780-1d6a99b39-b8a5-a426-e053-dadaa90af4c20964 ALPRAZOLAM ER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-964-30ALPRAZOLAMER30 in 1 BOTTLETABLET, EXTENDED RELEASE301
52959-964-60ALPRAZOLAMER60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-964ALPRAZOLAM ER (ALPRAZOLAM) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 2 package rows20190116_79619e0f-1600-40ea-e053-2a91aa0a2700.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN79619e0f-1600-40ea-e053-2a91aa0a27001
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD79619e0f-1600-40ea-e053-2a91aa0a27001
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY79619e0f-1600-40ea-e053-2a91aa0a27001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52959-964-305295909643030 TABLET, EXTENDED RELEASE in 1 BOTTLE (52959-964-30) 2015-12-140000-00-00NoNoCurrent
52959-964-605295909646060 TABLET, EXTENDED RELEASE in 1 BOTTLE (52959-964-60) 2015-12-140000-00-00NoNoCurrent