VALACYCLOVIR HYDROCHLORIDE (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Valacyclovir Hydrochloride

GENERIC: Valacyclovir Hydrochloride

DOSAGE: Film-coated Tablets, USP

ADMINSTRATION: Oral

NDC: 64679-152-01

STRENGTH: 500 mg

COLOR: Blue

SHAPE: Capsule

SCORE: no score

SIZE: 19 mm

IMPRINT: W152

QTY: 30 Tablets

Label
(click image for full-size original)

DRUG: Valacyclovir Hydrochloride

GENERIC: Valacyclovir Hydrochloride

DOSAGE: Film-coated Tablets, USP

ADMINSTRATION: Oral

NDC: 64679-153-01

STRENGTH: 1 g

COLOR: Blue

SHAPE: Capsule

SCORE: Scored

SIZE: 23 mm

IMPRINT: W153

QTY: 30 Tablets

Label
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-152
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K90
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE (capsule-shaped) Size 19mm
Flavor Imprint Code W152
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-152-05 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (64679-152-05)
2 NDC:64679-152-01 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:64679-152-03 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:64679-152-04 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090216 05/24/2010
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-153
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K90
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE (capsule-shaped) Size 23mm
Flavor Imprint Code W153
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-153-01 21 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64679-153-02 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:64679-153-03 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:64679-153-06 250 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:64679-153-04 500 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:64679-153-05 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (64679-153-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090216 05/24/2010
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Atlantide Pharmaceuticals AG (480475252)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 analysis (64679-152), analysis (64679-153), manufacture (64679-152), manufacture (64679-153), label (64679-152), label (64679-153), pack (64679-152), pack (64679-153)

Revised: 12/2020 Wockhardt USA LLC.

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