Alfuzosin Hydrochloride

Product NDC
64679-738
11-digit product format
646790738
Labeler code
64679
Product ID
64679-738_7631f701-1534-42fa-b1ff-7dfee0c2db7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA090221
Marketing category
ANDA
Marketing start
2012-08-15
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-738-02EA - Each64679-7387f1b2dbd-d11c-47e5-8316-5b4e237aeab912013-02-13
64679-738-03EA - Each64679-738476ef13e-b45b-4f6c-a773-9eeba5fb629c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-738ALFUZOSIN HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]4Legacy NDC20191128_f861c40a-504b-42c0-a17d-af35c0f187f9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-738-016467907380130 TABLET in 1 BOTTLE (64679-738-01) 30 tablet2012-08-150000-00-00NoNoCurrent
64679-738-0264679073802100 TABLET in 1 BOTTLE (64679-738-02) 100 tablet2012-08-150000-00-00NoNoCurrent
64679-738-0364679073803500 TABLET in 1 BOTTLE (64679-738-03) 500 tablet2012-08-150000-00-00NoNoCurrent
64679-738-056467907380510 BLISTER PACK in 1 CARTON (64679-738-05) > 10 TABLET in 1 BLISTER PACK10 blister pack2012-08-150000-00-00NoNoCurrent