Valacyclovir (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-7587

Valacyclovir HCI Tablets 1gm
(click image for full-size original)
VALACYCLOVIR valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7587(NDC:31722-705)
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%)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code I;87
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7587-4 4 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7587-0 6 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7587-1 10 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68788-7587-5 15 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:68788-7587-2 20 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:68788-7587-7 21 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:68788-7587-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203047 05/25/2015
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-7587)

Revised: 11/2019 Preferred Pharmaceuticals, Inc.

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