FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
57237-114
11-digit product format
572370114
Labeler code
57237
Product ID
57237-114_c759b18f-8985-4b41-852f-2aa423b32748
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA079060
Marketing category
ANDA
Marketing start
2012-08-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alfuzosin Hydrochloride
Listing expiration
2027-12-31

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
57237-114-01Alfuzosin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
57237-114-05Alfuzosin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5008
57237-114-90Alfuzosin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-114-90EA - Each57237-114c2626247-c93d-40ea-82ac-f388b6742f4f12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-114ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy NDC, 3 package rows20240110_43675e9d-a361-4109-9ae1-54d80580fbbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN43675e9d-a361-4109-9ae1-54d80580fbbd8
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD43675e9d-a361-4109-9ae1-54d80580fbbd8
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY43675e9d-a361-4109-9ae1-54d80580fbbd8
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN37e89394-af6e-4700-bfa8-2effba1a286b2
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNf2a530bd-6a86-251d-e053-2995a90adac42
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD37e89394-af6e-4700-bfa8-2effba1a286b2
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDf2a530bd-6a86-251d-e053-2995a90adac42
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY37e89394-af6e-4700-bfa8-2effba1a286b2
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYf2a530bd-6a86-251d-e053-2995a90adac42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-114-0157237011401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-01) 2012-08-300000-00-00NoNoCurrent
57237-114-0557237011405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-05) 2012-08-300000-00-00NoNoCurrent
57237-114-905723701149090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-90) 2012-08-300000-00-00NoNoCurrent