FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
71335-2146
11-digit product format
713352146
Labeler code
71335
Product ID
71335-2146_20858b72-0778-46d6-be98-37d913c425b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079057
Marketing category
ANDA
Marketing start
2011-11-22
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
71335-2146-1Alfuzosin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE30104
71335-2146-2Alfuzosin Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE60104
71335-2146-3Alfuzosin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE90104
71335-2146-4Alfuzosin Hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE120104
71335-2146-5Alfuzosin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2146ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240420_98fa10c2-7c12-44aa-9112-e2fd6fa71d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN98fa10c2-7c12-44aa-9112-e2fd6fa71d06104
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD98fa10c2-7c12-44aa-9112-e2fd6fa71d06104
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY98fa10c2-7c12-44aa-9112-e2fd6fa71d06104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2146-17133521460130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-1) 2024-04-030000-00-00NoNoCurrent
71335-2146-27133521460260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-2) 2024-04-030000-00-00NoNoCurrent
71335-2146-37133521460390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-3) 2023-01-300000-00-00NoNoCurrent
71335-2146-471335214604120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-4) 2024-04-030000-00-00NoNoCurrent
71335-2146-571335214605100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-5) 2024-04-03NoNoHistorical