FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
55648-738
11-digit product format
556480738
Labeler code
55648
Product ID
55648-738_684641a9-69ac-47dc-9fc5-3dc6c9b4028c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA090221
Marketing category
ANDA
Marketing start
2012-08-15
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b671e1a-6f8a-5de4-69a7-83132df7952dProduct name320201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-738-012020-01-31C16284748780-19d75b9d0-efe3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin HCl extended-release tablets safely and effectively. See full prescribing information for alfuzosin HCl extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003
55648-738-022020-01-31C16284748780-19d75b9d0-efe3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin HCl extended-release tablets safely and effectively. See full prescribing information for alfuzosin HCl extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003
55648-738-032020-01-31C16284748780-19d75b9d0-efe3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin HCl extended-release tablets safely and effectively. See full prescribing information for alfuzosin HCl extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003
55648-738-052020-01-31C16284748780-19d75b9d0-efe3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin HCl extended-release tablets safely and effectively. See full prescribing information for alfuzosin HCl extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-738-01Alfuzosin Hydrochloride30 in 1 BOTTLETABLET301
55648-738-02Alfuzosin Hydrochloride100 in 1 BOTTLETABLET1001
55648-738-03Alfuzosin Hydrochloride500 in 1 BOTTLETABLET5001
55648-738-05Alfuzosin Hydrochloride10 in 1 CARTONTABLET101
55648-738-05Alfuzosin Hydrochloride10 in 1 BLISTER PACKTABLET101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-738ALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1Legacy NDC, 5 package rows20120815_30f97b8e-4486-4b5f-896a-d7dfa1e2e33a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN30f97b8e-4486-4b5f-896a-d7dfa1e2e33a1
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD30f97b8e-4486-4b5f-896a-d7dfa1e2e33a1
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY30f97b8e-4486-4b5f-896a-d7dfa1e2e33a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-738-015564807380130 in 1 BOTTLEHistorical
55648-738-0255648073802100 in 1 BOTTLEHistorical
55648-738-0355648073803500 in 1 BOTTLEHistorical
55648-738-055564807380510 in 1 CARTONHistorical