FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
70934-306
11-digit product format
709340306
Labeler code
70934
Product ID
70934-306_d17a80ba-2b1c-abd0-e053-2a95a90a1f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA079057
Marketing category
ANDA
Marketing start
2019-03-21
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
2022-12-31
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
70934-306-302023-01-30C16284748780-1f386c649-ab23-0266-e053-dadaa90a7c1aThese 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, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-306-30Alfuzosin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-306ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 1 package rows20211229_8b256346-9450-54b5-e053-2995a90ae259.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN8b256346-9450-54b5-e053-2995a90ae2593
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD8b256346-9450-54b5-e053-2995a90ae2593
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY8b256346-9450-54b5-e053-2995a90ae2593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-306-307093403063030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-306-30) 2019-03-210000-00-00NoNoCurrent