FDA.reportPublic FDA data

Alfuzosin hydrochloride

Product NDC
43353-945
11-digit product format
433530945
Labeler code
43353
Product ID
43353-945_15c875e9-bc9e-4d06-83f5-0cc5c6742302
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090284
Marketing category
ANDA
Marketing start
2012-10-02
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
43353-945-16Alfuzosin hydrochloride6000 in 1 BOTTLETABLET, EXTENDED RELEASE60002
43353-945-30Alfuzosin hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
43353-945-60Alfuzosin hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-945-16EA - Each43353-94538a9ed03-aecc-403d-86d0-c8eb739b055a12018-01-12
43353-945-30EA - Each43353-9453435a6c9-9acb-4ee4-bffe-88a5a0e6f51e12018-01-12
43353-945-60EA - Each43353-9452dcd0a4f-edd6-4315-90b7-31fcc1f35aa412018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-945ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20171223_790fe381-4a83-402e-b6c0-2ecde9cac7a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN790fe381-4a83-402e-b6c0-2ecde9cac7a72
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD790fe381-4a83-402e-b6c0-2ecde9cac7a72
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY790fe381-4a83-402e-b6c0-2ecde9cac7a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-945-16433530945166000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-16) 2014-05-220000-00-00NoNoCurrent
43353-945-304335309453030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-30) 2015-04-020000-00-00NoNoCurrent
43353-945-604335309456090 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-60) 2015-04-020000-00-00NoNoCurrent