FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
33261-994
11-digit product format
332610994
Labeler code
33261
Product ID
33261-994_49778501-d326-4ead-9fa5-b9d30228ff2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA079057
Marketing category
ANDA
Marketing start
2011-11-22
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
33261-994-302020-01-31C16284748780-19d75b9d1-07e0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003
33261-994-602020-01-31C16284748780-19d75b9d1-07e0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003
33261-994-902020-01-31C16284748780-19d75b9d1-07e0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-994-30Alfuzosin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302
33261-994-60Alfuzosin Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE602
33261-994-90Alfuzosin Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-994-30EA - Each33261-994834c01a6-338c-4d3d-a0ed-f259e96e52d212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-994ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 3 package rows20131204_94458f26-9269-4fbc-80db-adc43b1fc62f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN94458f26-9269-4fbc-80db-adc43b1fc62f2
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD94458f26-9269-4fbc-80db-adc43b1fc62f2
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY94458f26-9269-4fbc-80db-adc43b1fc62f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-994-303326109943030 in 1 BOTTLE, PLASTICHistorical
33261-994-603326109946060 in 1 BOTTLE, PLASTICHistorical
33261-994-903326109949090 in 1 BOTTLE, PLASTICHistorical