Acyclovir (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acyclovir Tablets USP, 400 mg — 100s count

400-mg
(click image for full-size original)

Acyclovir Tablets USP, 800 mg — 100s count

800-mg
(click image for full-size original)
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-777
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color pink Score no score
Shape HEXAGON (6 sided) (shield,flat) Size 12mm
Flavor Imprint Code J;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-777-01 100 TABLET in 1 BOTTLE None
2 NDC:31722-777-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203834 11/29/2013
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-778
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 2
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color blue Score no score
Shape OVAL (biconvex) Size 19mm
Flavor Imprint Code J;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-778-01 100 TABLET in 1 BOTTLE None
2 NDC:31722-778-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203834 11/29/2013
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Registrant — Hetero Labs Limited Unit V (650452530)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit V 650452530 analysis (31722-777), analysis (31722-778), manufacture (31722-777), manufacture (31722-778)

Revised: 04/2021 Camber Pharmaceuticals, Inc.

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