Alfuzosin Hydrochloride

Product NDC
51655-432
11-digit product format
516550432
Labeler code
51655
Product ID
51655-432_490ec676-81a7-6ba1-e063-6394a90a5039
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA079057
Marketing category
ANDA
Marketing start
2020-09-09
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
51655-432-52Alfuzosin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-432ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20250101_f2f42c98-4118-5f70-e053-2a95a90add02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-432-525165504325230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-432-52) 2020-09-09NoNoHistorical