Valacyclovir Hydrochloride (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

NDC 0781-5208-31

Valacyclovir Tablets, USP

500 mg*

Rx Only 30 Tablets

PHARMACIST: Dispense the Patient Information Leaflet with the Drug Product.

500 mg label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0781-5209-31

Valacyclovir Tablets, USP

1 gm*

Rx only 30 Tablets

PHARMACIST: Dispense the Patient Information Leaflet with the Drug Product.

1 gm label
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5208
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
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code SZ;393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-5208-31 30 TABLET in 1 BOTTLE None
2 NDC:0781-5208-92 90 TABLET in 1 BOTTLE None
3 NDC:0781-5208-01 100 TABLET in 1 BOTTLE None
4 NDC:0781-5208-05 500 TABLET in 1 BOTTLE None
5 NDC:0781-5208-13 100 TABLET in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077478 05/24/2010
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5209
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
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code SZ;394
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-5209-31 30 TABLET in 1 BOTTLE None
2 NDC:0781-5209-92 90 TABLET in 1 BOTTLE None
3 NDC:0781-5209-01 100 TABLET in 1 BOTTLE None
4 NDC:0781-5209-05 500 TABLET in 1 BOTTLE None
5 NDC:0781-5209-13 100 TABLET in 1 BOX, UNIT-DOSE None
6 NDC:0781-5209-27 21 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077478 05/24/2010
Labeler — Sandoz Inc. (005387188)

Revised: 06/2021 Sandoz Inc.

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