Valacyclovir Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59746-324-30
CADISTATM
Valacyclovir Tablets, USP
500 mg
30 Tablets Rx Only Pharmacist: Dispense the accompanying patient information leaflet to each patient.

label1
(click image for full-size original)

500 mg Bottle Label

NDC 59746-325-30
CADISTATM
Valacyclovir Tablets, USP
1 gram

30 Tablets Rx Only Pharmacist: Dispense the accompanying patient information leaflet to each patient.

label2
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-324
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
FD&C BLUE NO. 2
Hypromelloses
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Polyethylene Glycols
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE (capsule shaped) Size 18mm
Flavor Imprint Code C324500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-324-10 10 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59746-324-30 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:59746-324-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:59746-324-01 100 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:59746-324-37 250 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:59746-324-47 300 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201506 04/05/2012
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-325
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
FD&C BLUE NO. 2
Hypromelloses
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Polyethylene Glycols
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE (capsule shaped) Size 23mm
Flavor Imprint Code C3251000
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-325-10 10 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59746-325-30 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:59746-325-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:59746-325-01 100 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:59746-325-37 250 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:59746-325-47 300 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201506 04/05/2012
Labeler — Jubilant Cadista Pharmaceuticals Inc. (022490515)
Registrant — Jubilant Generics Limited (650801538)
Establishment
Name Address ID/FEI Operations
Jubilant Generics Limited 650369221 MANUFACTURE (59746-324), MANUFACTURE (59746-325)

Revised: 06/2016 Jubilant Cadista Pharmaceuticals Inc.

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