Valacyclovir Hydrochloride (Page 13 of 13)

PRINCIPAL DISPLAY PANEL – 500 mg

NDC 0378-4275-93

Valacyclovir
Tablets, USP
500 mg

Rx only 30 Tablets

Each film-coated tablet contains 500 mg
of valacyclovir equivalent to 556.2 mg of
valacyclovir hydrochloride, USP (hydrous)
per tablet.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Do not use if safety seal under cap is
broken or missing.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX4275H7

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Valacyclovir Tablets 500 mg  Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 1 g

NDC 0378-4276-93

Valacyclovir
Tablets, USP
1 gram

Rx only 30 Tablets

Each film-coated tablet contains 1 gram of
valacyclovir equivalent to 1.112 grams of
valacyclovir hydrochloride, USP (hydrous)
per tablet.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Do not use if safety seal under cap is
broken or missing.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX4276H7

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Valacyclovir Tablets 1 gram Bottle Label
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4275
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
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code M122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-4275-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-4275-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078518 05/24/2010
VALACYCLOVIR HYDROCHLORIDE valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4276
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
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 21mm
Flavor Imprint Code M123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-4276-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-4276-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078518 05/24/2010
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 06/2021 Mylan Pharmaceuticals Inc.

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