FDA.reportPublic FDA data

Alfuzosin hydrochloride

Product NDC
76282-302
11-digit product format
762820302
Labeler code
76282
Product ID
76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
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
76282-302-01Alfuzosin hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10011
76282-302-05Alfuzosin hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50011
76282-302-10Alfuzosin hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011
76282-302-12Alfuzosin hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE12011
76282-302-90Alfuzosin hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-302-01EA - Each76282-302adb2582e-2546-4a3e-85b0-b639f174b52d12013-02-13
76282-302-05EA - Each76282-30235f5e404-f900-4ccd-82eb-846b095cc80e12014-05-02
76282-302-10EA - Each76282-302aa84c026-2961-435c-af6c-292205a0b24c12024-07-12
76282-302-12EA - Each76282-302a263f4e1-df21-4a73-bf23-5512d8ccb1c412023-04-07
76282-302-90EA - Each76282-302ae9b4a7f-2960-4d72-b371-90aff5e1602312019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]2
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]2
GUAR GUMINACTIVE INGREDIENTE89I1637KEALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE ) TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-302ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 5 package rows20240605_f075a897-7bef-4799-b7e2-7e051c461443.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNf075a897-7bef-4799-b7e2-7e051c46144311
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDf075a897-7bef-4799-b7e2-7e051c46144311
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYf075a897-7bef-4799-b7e2-7e051c46144311
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
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-302-0176282030201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01) 2012-10-020000-00-00NoNoCurrent
76282-302-0576282030205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05) 2012-10-020000-00-00NoNoCurrent
76282-302-10762820302101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10) 2012-10-02NoNoCurrent
76282-302-1276282030212120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12) 2022-12-010000-00-00NoNoCurrent
76282-302-907628203029090 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90) 2019-01-010000-00-00NoNoCurrent