FDA.reportPublic FDA data

Alfuzosin hydrochloride

Product NDC
0440-5000
11-digit product format
004405000
Labeler code
0440
Product ID
0440-5000_a588f193-6be7-4048-bb99-970d8925c760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA090284
Marketing category
ANDA
Marketing start
2012-10-02
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
E
Listing certified through
2018-12-31
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
0440-5000-902020-01-31C16284748780-19d75b9cf-f4d0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-5000-90Alfuzosin hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-5000-90EA - Each0440-5000975d7d41-9229-42be-b9dd-c7ba33028e3f12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-5000ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20160810_8a677905-e66d-44f7-b564-6c561387ed03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN8a677905-e66d-44f7-b564-6c561387ed031
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD8a677905-e66d-44f7-b564-6c561387ed031
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY8a677905-e66d-44f7-b564-6c561387ed031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-5000-900044050009090 in 1 BOTTLEHistorical