FDA.reportPublic FDA data

NDC 60505-2850-09 - Alfuzosin Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60505-2850
Requested NDC
60505-2850-09
Package NDCs from labels
60505-2850-3, 60505-2850-1, 60505-2850-5, 60505-2850-8, 60505-2850-7, 60505-2850-0, 60505-2850-9, 60505-2850-09
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alfuzosin Hydrochloride - Apotex Corp. | Apotex Inc.Apotex Corp. | Apotex Inc.2026-09-03HUMAN PRESCRIPTION DRUG LABEL
Alfuzosin Hydrochloride - Golden State Medical Supply, Inc.Golden State Medical Supply, Inc.2023-10-09HUMAN PRESCRIPTION DRUG LABEL
Alfuzosin Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-04-05HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEApotex Corp.26fcc267-c8d7-e059-1bcf-830dded436902026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA079013
ndc (package): 60505-2850-0
ndc (package): 60505-2850-7
ndc (package): 60505-2850-3
ndc (package): 60505-2850-1
ndc (package): 60505-2850-5
ndc (package): 60505-2850-8
ndc (package): 60505-2850-9
ndc (product): 60505-2850
ndc11 (package): 60505285009
rxcui: 861132
spl id: 42042f92-9e44-3c65-d85d-af81918b0d4e
spl set id: 26fcc267-c8d7-e059-1bcf-830dded43690
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEAurobindo Pharma Limitedd163369b-e44b-4591-b166-7ddd0c1c13c02026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEAurobindo Pharma Limited8811cb59-6826-41d5-ab68-567338a4b8832026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack37e89394-af6e-4700-bfa8-2effba1a286b2026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: O7TSZ97GEP
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDENorthwind Health Company, LLCf2f42c98-4118-5f70-e053-2a95a90add022026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDENorthwind Health Company, LLCffbd22eb-9df5-e0ad-e053-6294a90a7d4e2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDERising Pharma Holdings, Inc.43675e9d-a361-4109-9ae1-54d80580fbbd2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDENorthwind Health Company, LLCf2a530bd-6a86-251d-e053-2995a90adac42025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
28f3781c-4ae2-dd53-e063-6394a90a65c1074f9deb-0ace-4292-e063-6294a90aae922024-12-10Warnings, Adverse reactionsExact identifier
spl set id: 074f9deb-0ace-4292-e063-6294a90aae92
UroxatralALFUZOSIN HCLAdvanz Pharma (US) Corp.9fc7f119-f36b-44cf-945d-940160f3afe32024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack3a541efa-9eed-4a27-b602-7999fc6f59aa2024-07-16Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepackc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda2024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack98fa10c2-7c12-44aa-9112-e2fd6fa71d062024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.d2af616e-673a-4fdd-ace8-db2d0f1546042024-01-19Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEExelan Pharmaceuticals Inc.f075a897-7bef-4799-b7e2-7e051c4614432023-10-01Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.644295a9-75cb-4326-a71f-b0f4e0c4cf752022-03-25Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN
Alfuzosin Hydrochloride extended releaseALFUZOSIN HYDROCHLORIDECipla USA Inc.3cc028d5-309f-4ce3-a2d7-5804ab57677d2020-10-01Warnings, Adverse reactionsExact identifier
rxcui: 861132
unii: 75046A1XTN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.