FDA.reportPublic FDA data

Alfuzosin Hydrochloride

Product NDC
69097-844
11-digit product format
690970844
Labeler code
69097
Product ID
69097-844_497e0a60-9b09-4dcc-8cc6-1f13196f2db4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA090284
Marketing category
ANDA
Marketing start
2016-06-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alfuzosin Hydrochloride
Brand name suffix
extended release
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
69097-844-02Alfuzosin Hydrochlorideextended release30 in 1 BOTTLETABLET304
69097-844-05Alfuzosin Hydrochlorideextended release90 in 1 BOTTLETABLET904
69097-844-07Alfuzosin Hydrochlorideextended release100 in 1 BOTTLETABLET1004
69097-844-12Alfuzosin Hydrochlorideextended release500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-844-07EA - Each69097-844e77c0292-3c7e-4745-9842-0ec4f2ed029d12016-07-19
69097-844-12EA - Each69097-844abb94301-dbff-4c0d-80c6-792120c75ac512016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-844ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE (ALFUZOSIN HYDROCHLORIDE) TABLET [CIPLA USA INC.]4Current NDC, Legacy NDC, 4 package rows20201008_3cc028d5-309f-4ce3-a2d7-5804ab57677d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN3cc028d5-309f-4ce3-a2d7-5804ab57677d4
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD3cc028d5-309f-4ce3-a2d7-5804ab57677d4
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY3cc028d5-309f-4ce3-a2d7-5804ab57677d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-844-026909708440230 TABLET in 1 BOTTLE (69097-844-02) 30 tablet2016-06-300000-00-00NoNoCurrent
69097-844-056909708440590 TABLET in 1 BOTTLE (69097-844-05) 90 tablet2016-06-300000-00-00NoNoCurrent
69097-844-0769097084407100 TABLET in 1 BOTTLE (69097-844-07) 100 tablet2016-06-300000-00-00NoNoCurrent
69097-844-1269097084412500 TABLET in 1 BOTTLE (69097-844-12) 500 tablet2016-06-300000-00-00NoNoCurrent