FDA.reportPublic FDA data

Uroxatral

Product NDC
59212-200
11-digit product format
592120200
Labeler code
59212
Product ID
59212-200_ffbc758d-7556-4269-8947-baa7ddb88541
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Application
NDA021287
Marketing category
NDA
Marketing start
2013-06-03
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
Uroxatral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALFUZOSIN HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75046A1XTN
Rxcui861132, 861134

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
59212-200-10Uroxatral100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
59212-200-30Uroxatral30 in 1 BOTTLETABLET, EXTENDED RELEASE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-200-10EA - Each59212-200849e6e99-7b1b-4f99-9c34-9cfd9f8025e912015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alfuzosin hydrochlorideACTIVE INGREDIENT75046A1XTNUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
alfuzosinACTIVE MOIETY90347YTW5FUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
ethylcellulose (100 mpa.s)INACTIVE INGREDIENT47MLB0F1MVUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
hydrogenated castor oilINACTIVE INGREDIENTZF94AP8MEYUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
mannitolINACTIVE INGREDIENT3OWL53L36AUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
povidonesINACTIVE INGREDIENTFZ989GH94EUROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-200UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [ADVANZ PHARMA (US) CORP.]9Current NDC, Legacy NDC, 2 package rows20250103_9fc7f119-f36b-44cf-945d-940160f3afe3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN9fc7f119-f36b-44cf-945d-940160f3afe39
861134Uroxatral 10 MG 24HR Extended Release Oral TabletPSN9fc7f119-f36b-44cf-945d-940160f3afe39
86113424 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet [UroXatral]SBD9fc7f119-f36b-44cf-945d-940160f3afe39
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD9fc7f119-f36b-44cf-945d-940160f3afe39
86113424 HR UroXatral 10 MG Extended Release Oral TabletSY9fc7f119-f36b-44cf-945d-940160f3afe39
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY9fc7f119-f36b-44cf-945d-940160f3afe39
861134Uroxatral 10 MG 24 HR Extended Release Oral TabletSY9fc7f119-f36b-44cf-945d-940160f3afe39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59212-200-1059212020010100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10) 2013-06-030000-00-00NoNoCurrent
59212-200-305921202003030 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30) 2019-01-180000-00-00NoNoCurrent