Alfuzosin Hydrochloride

Product NDC
71335-2578
11-digit product format
713352578
Labeler code
71335
Product ID
71335-2578_7ce6f1ee-cf32-445d-a682-b01823587446
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079060
Marketing category
ANDA
Marketing start
2012-08-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alfuzosin Hydrochloride
Listing expiration
2027-12-31

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
71335-2578-1Alfuzosin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71335-2578-2Alfuzosin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
71335-2578-3Alfuzosin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902
71335-2578-4Alfuzosin Hydrochloride120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1202
71335-2578-5Alfuzosin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2578ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20250209_37e89394-af6e-4700-bfa8-2effba1a286b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN37e89394-af6e-4700-bfa8-2effba1a286b2
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD37e89394-af6e-4700-bfa8-2effba1a286b2
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY37e89394-af6e-4700-bfa8-2effba1a286b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2578-17133525780130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-1) 2025-02-06NoNoHistorical
71335-2578-27133525780260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-2) 2025-02-06NoNoHistorical
71335-2578-37133525780390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-3) 2025-02-06NoNoHistorical
71335-2578-471335257804120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-4) 2025-02-06NoNoHistorical
71335-2578-571335257805100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-5) 2025-02-06NoNoHistorical