Valacyclovir Hydrochloride (Page 9 of 9)

SPL PATIENT PACKAGE INSERT SECTION

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC # 49483-690-04
Valacyclovir Tablets USP 500 mg
100s count (10×10) unit dose package label

500-carton
(click image for full-size original)

NDC # 49483-690-03
Valacyclovir Tablets USP 500 mg
30s count bottle label
500-30s
(click image for full-size original)

NDC # 49483-690-41
Valacyclovir Tablets USP 500 mg
42s count bottle label

500-42s
(click image for full-size original)

NDC # 49483-690-50
Valacyclovir Tablets USP 500 mg
500s count bottle label

500-500s
(click image for full-size original)

NDC # 49483-691-04
Valacyclovir Tablets USP 1 gm
100s count (10×10) unit dose package label

1gm-carton
(click image for full-size original)

NDC # 49483-691-03
Valacyclovir Tablets USP 1 gm
30s count bottle label

1gm-30s
(click image for full-size original)

NDC # 49483-691-01
Valacyclovir Tablets USP 1 gm
100s count bottle label

1gm-100s
(click image for full-size original)

NDC # 49483-691-50
Valacyclovir Tablets USP 1 gm
500s count bottle label

1gm-500s
(click image for full-size original)

VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-690
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
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
FD&C BLUE NO. 2
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
CARNAUBA WAX
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code RDY;552
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-690-03 30 TABLET in 1 BOTTLE None
2 NDC:49483-690-41 42 TABLET in 1 BOTTLE None
3 NDC:49483-690-50 500 TABLET in 1 BOTTLE None
4 NDC:49483-690-04 10 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079012 07/14/2021
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-691
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
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
FD&C BLUE NO. 2
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
CARNAUBA WAX
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code RDY;553
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-691-03 30 TABLET in 1 BOTTLE None
2 NDC:49483-691-50 500 TABLET in 1 BOTTLE None
3 NDC:49483-691-04 10 TABLET in 1 BLISTER PACK None
4 NDC:49483-691-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079012 07/14/2021
Labeler — TIME CAP LABORATORIES, INC. (037052099)
Registrant — TIME CAP LABORATORIES, INC. (037052099)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 manufacture (49483-690), manufacture (49483-691)

Revised: 07/2021 TIME CAP LABORATORIES, INC.

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