Valacyclovir Hydrochloride (Page 8 of 8)

Principal Display Panel

NDC: 70934-301-14

Label
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-301(NDC:69097-153)
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
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYDROGENATED CASTOR OIL
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code CIPLA153
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-301-14 14 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077135 03/01/2019
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-301)

Revised: 12/2020 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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