FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
47335-956
11-digit product format
473350956
Labeler code
47335
Product ID
47335-956_70258299-7c72-4a10-8d0c-4a5e3b2a0fc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA079057
Marketing category
ANDA
Marketing start
2011-11-22
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
47335-956-08Alfuzosin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10015
47335-956-18Alfuzosin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100015
47335-956-81Alfuzosin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9015
47335-956-83Alfuzosin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3015
47335-956-88Alfuzosin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-956-18EA - Each47335-9567b08db97-7ad5-4659-b8f5-ce1eec53d17112012-07-24
47335-956-81EA - Each47335-956603c57cc-9d96-49c6-97ca-fe083414978a12012-07-24
47335-956-88EA - Each47335-9566f86c33a-e20b-4cff-bbff-2d87b832230712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
TALCINACTIVE INGREDIENT7SEV7J4R1UALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]8
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
47335-956ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]15Current NDC, Legacy NDC, 5 package rows20240120_d2af616e-673a-4fdd-ace8-db2d0f154604.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN98fa10c2-7c12-44aa-9112-e2fd6fa71d06104
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD98fa10c2-7c12-44aa-9112-e2fd6fa71d06104
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY98fa10c2-7c12-44aa-9112-e2fd6fa71d06104
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN3a541efa-9eed-4a27-b602-7999fc6f59aa100
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD3a541efa-9eed-4a27-b602-7999fc6f59aa100
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY3a541efa-9eed-4a27-b602-7999fc6f59aa100
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNd2af616e-673a-4fdd-ace8-db2d0f15460415
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDd2af616e-673a-4fdd-ace8-db2d0f15460415
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYd2af616e-673a-4fdd-ace8-db2d0f15460415
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNf2f42c98-4118-5f70-e053-2a95a90add024
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDf2f42c98-4118-5f70-e053-2a95a90add024
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYf2f42c98-4118-5f70-e053-2a95a90add024
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN8b256346-9450-54b5-e053-2995a90ae2593
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD8b256346-9450-54b5-e053-2995a90ae2593
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY8b256346-9450-54b5-e053-2995a90ae2593
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN94458f26-9269-4fbc-80db-adc43b1fc62f2
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN27f6bec9-90a9-4c4c-e054-00144ff8d46c2
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD94458f26-9269-4fbc-80db-adc43b1fc62f2
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD27f6bec9-90a9-4c4c-e054-00144ff8d46c2
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY94458f26-9269-4fbc-80db-adc43b1fc62f2
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY27f6bec9-90a9-4c4c-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-956-0847335095608100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-08) 2011-11-220000-00-00NoNoCurrent
47335-956-18473350956181000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-18) 2011-11-220000-00-00NoNoCurrent
47335-956-814733509568190 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-81) 2011-11-220000-00-00NoNoCurrent
47335-956-834733509568330 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-83) 2011-11-220000-00-00NoNoCurrent
47335-956-8847335095688100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-88) 2011-11-220000-00-00NoNoCurrent