FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
60505-2850
11-digit product format
605052850
Labeler code
60505
Product ID
60505-2850_5632aa3d-c35f-10fe-3ad1-7d1632a1c1c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA079013
Marketing category
ANDA
Marketing start
2023-09-08
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
60505-2850-0Alfuzosin Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1017
60505-2850-0Alfuzosin Hydrochloride10 in 1 CARTONTABLET, EXTENDED RELEASE1017
60505-2850-1Alfuzosin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10017
60505-2850-3Alfuzosin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3017
60505-2850-5Alfuzosin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50017
60505-2850-7Alfuzosin Hydrochloride8000 in 1 BOTTLETABLET, EXTENDED RELEASE800017
60505-2850-8Alfuzosin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100017
60505-2850-9Alfuzosin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2850-1EA - Each60505-28502c52c81d-8c40-4802-a882-a7b1d7d83dfb12012-07-24
60505-2850-9EA - Each60505-2850e1ebb5f6-08bf-49f5-8b86-3430ac551bc312023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2850ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]17Current NDC, Legacy NDC, 8 package rows20250412_26fcc267-c8d7-e059-1bcf-830dded43690.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN26fcc267-c8d7-e059-1bcf-830dded4369017
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD26fcc267-c8d7-e059-1bcf-830dded4369017
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY26fcc267-c8d7-e059-1bcf-830dded4369017
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN0feb7a22-7416-4502-bf6e-6341782d11ab3
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD0feb7a22-7416-4502-bf6e-6341782d11ab3
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY0feb7a22-7416-4502-bf6e-6341782d11ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-2850-06050528500010 in 1 BLISTER PACKHistorical
60505-2850-160505285001100 in 1 BOTTLEHistorical
60505-2850-36050528500330 in 1 BOTTLEHistorical
60505-2850-560505285005500 in 1 BOTTLEHistorical
60505-2850-7605052850078000 in 1 BOTTLEHistorical
60505-2850-8605052850081000 in 1 BOTTLEHistorical
60505-2850-96050528500990 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-2850-9) 2023-09-08NoNoHistorical