FDA.reportPublic FDA data

Alfuzosin hydrochloride

Product NDC
63629-9155
11-digit product format
636299155
Labeler code
63629
Product ID
63629-9155_f10b905b-346c-493f-ad51-54c0b9e0d3a4
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
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alfuzosin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALFUZOSIN HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75046A1XTN
Rxcui861132

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9155-1Alfuzosin hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30103
63629-9155-2Alfuzosin hydrochloride60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE60103
63629-9155-3Alfuzosin hydrochloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90103
63629-9155-4Alfuzosin hydrochloride120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE120103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9155ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20240524_c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda103
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda103
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9155-16362991550130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-1) 2022-04-290000-00-00NoNoCurrent
63629-9155-26362991550260 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-2) 2022-04-290000-00-00NoNoCurrent
63629-9155-36362991550390 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-3) 2022-04-290000-00-00NoNoCurrent
63629-9155-463629915504120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-4) 2022-04-290000-00-00NoNoCurrent