Alfuzosin Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Alfuzosin Hydrochloride

GENERIC: Alfuzosin Hydrochloride

DOSAGE: Extended-Release Tablets

ADMINSTRATION: Oral

NDC: 64679-738-01

STRENGTH: 10 mg

COLOR: WHITE (White) , YELLOW (Yellow)

SHAPE: ROUND (bi-layered circular shaped standard convex tablets)

SCORE: no score

SIZE: 20 mm

IMPRINT: W738

QTY: 30 Tablets

Label
(click image for full-size original)

DRUG: Alfuzosin Hydrochloride

GENERIC: Alfuzosin Hydrochloride

DOSAGE: Extended-Release Tablets

ADMINSTRATION: Oral

NDC: 64679-738-03

STRENGTH: 10 mg

COLOR: WHITE (White) , YELLOW (Yellow)

SHAPE: ROUND (bi-layered circular shaped standard convex tablets)

SCORE: no score

SIZE: 20 mm

IMPRINT: W738

QTY: 500 Tablets

Label
(click image for full-size original)
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-738
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN) ALFUZOSIN HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE (TYPE M)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SILICON DIOXIDE
TALC
Product Characteristics
Color WHITE (White) , YELLOW (Yellow) Score no score
Shape ROUND (bi-layered circular shaped standard convex tablets) Size 20mm
Flavor Imprint Code W738
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-738-01 30 TABLET in 1 BOTTLE None
2 NDC:64679-738-02 100 TABLET in 1 BOTTLE None
3 NDC:64679-738-03 500 TABLET in 1 BOTTLE None
4 NDC:64679-738-05 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-738-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090221 08/15/2012
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 ANALYSIS (64679-738), MANUFACTURE (64679-738), LABEL (64679-738), PACK (64679-738)

Revised: 11/2019 Wockhardt USA LLC.

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