Alfuzosin Hydrochloride

Product NDC
51655-087
11-digit product format
516550087
Labeler code
51655
Product ID
51655-087_46ddcd42-e20f-656c-e063-6294a90a7e5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA079060
Marketing category
ANDA
Marketing start
2022-10-04
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
51655-087-52Alfuzosin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-087ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230216_f2a530bd-6a86-251d-e053-2995a90adac4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNf2a530bd-6a86-251d-e053-2995a90adac42
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDf2a530bd-6a86-251d-e053-2995a90adac42
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 startSampleExclude flagStatus
51655-087-525165500875230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-087-52) 2022-10-04NoNoHistorical