FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
43353-746
11-digit product format
433530746
Labeler code
43353
Product ID
43353-746_96bf130d-854d-4e51-834f-95df39f5c858
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alfuzosin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA079014
Marketing category
ANDA
Marketing start
2011-08-09
Marketing end
0000-00-00
Substance
ALFUZOSIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b671e1a-6f8a-5de4-69a7-83132df7952dProduct name320201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-746-302020-01-31C16284748780-19d75b9d0-08cb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets. ALFUZOSIN hydrochloride extended-release tablets, USP for oral use Initial U.S. Approval: 2003
43353-746-602020-01-31C16284748780-19d75b9d0-08cb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets. ALFUZOSIN hydrochloride extended-release tablets, USP for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-746-30Alfuzosin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301
43353-746-60Alfuzosin Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-746-30EA - Each43353-74695e75da2-3b5d-458e-bbc8-250c444edc5e12017-12-14
43353-746-60EA - Each43353-7461a755b5c-c308-4cc7-8596-e0cac7fa8f2312017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-746ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20171003_be2c5e2e-6435-4d0f-bf5c-79dbcab99ebb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNbe2c5e2e-6435-4d0f-bf5c-79dbcab99ebb1
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDbe2c5e2e-6435-4d0f-bf5c-79dbcab99ebb1
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYbe2c5e2e-6435-4d0f-bf5c-79dbcab99ebb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-746-304335307463030 in 1 BOTTLE, PLASTICHistorical
43353-746-604335307466090 in 1 BOTTLE, PLASTICHistorical