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

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 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.