FDA.reportPublic FDA data

Alfuzosin hydrochloride

Product NDC
63629-7907
11-digit product format
636297907
Labeler code
63629
Product ID
63629-7907_765f4f51-d655-4e24-bf8d-69eb03230e46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203192
Marketing category
ANDA
Marketing start
2016-03-15
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
2023-12-31
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
63629-7907-12024-01-30C16284748780-11030e365-6d3b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLET safely and effectively. See full prescribing information for ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. ALFUZOSIN hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7907-1Alfuzosin hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7907ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]3Legacy NDC, 1 package rows20220507_0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7907-16362979070190 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7907-1) 2019-02-050000-00-00NoNoCurrent