Acyclovir (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72578-101-04 in tube of 2 g

Acyclovir Cream, 5%

Rx only

2 g

Acyclovir Cream
(click image for full-size original)
Acyclovir Cream
(click image for full-size original)
ACYCLOVIR acyclovir cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
MINERAL OIL
PETROLATUM
POLOXAMER 407
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
WATER
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-101-04 1 TUBE in 1 CARTON contains a TUBE
1 2 g in 1 TUBE This package is contained within the CARTON (72578-101-04)
2 NDC:72578-101-05 1 TUBE in 1 CARTON contains a TUBE
2 5 g in 1 TUBE This package is contained within the CARTON (72578-101-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206770 03/03/2023
Labeler — Viona Pharmaceuticals Inc (081468959)
Registrant — Zydus Lifesciences Limited (650199482)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 650650802 ANALYSIS (72578-101), MANUFACTURE (72578-101)

Revised: 03/2023 Viona Pharmaceuticals Inc

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