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  • Acyclovir ACYCLOVIR SODIUM 50 mg/mL Zydus Lifesciences Limited
FDA Drug information

Acyclovir

Read time: 1 mins
Marketing start date: 03 May 2024
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Summary of product characteristics


Effective Time

20221017

Version

6

Spl Product Data Elements

acyclovir ACYCLOVIR ACYCLOVIR SODIUM ACYCLOVIR SODIUM HYDROXIDE WATER acyclovir ACYCLOVIR ACYCLOVIR SODIUM ACYCLOVIR SODIUM HYDROXIDE WATER

Application Number

ANDA206535

Brand Name

Acyclovir

Generic Name

ACYCLOVIR

Product Ndc

70771-1384

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PACKAGE LABEL - PRINCIPAL DISPLAY - 10 mL Single-Use Container Label NDC 70771- 1383 -1 Acyclovir Sodium Injection 500 mg/10 mL* (50 mg/mL) For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE 10 mL Single-Use Vial Rx only zydus pharmaceuticals PACKAGE LABEL - PRINCIPAL DISPLAY - 10 mL Single-Use Carton Label NDC 70771- 1383 -6 Acyclovir Sodium Injection 500 mg/10 mL* (50 mg/mL) For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE 10 x 10 mL Single-Use Vial Rx only zydus pharmaceuticals PACKAGE LABEL - PRINCIPAL DISPLAY - 20 mL Single-Use Container Label NDC 70771- 1384 -1 Acyclovir Sodium Injection 1000 mg/20 mL* (50 mg/mL) For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE 20 mL Single-Use Vial Rx only zydus pharmaceuticals PACKAGE LABEL - PRINCIPAL DISPLAY - 20 mL Single-Use Carton Label NDC 70771- 1384 -6 Acyclovir Sodium Injection 1000 mg/20 mL* (50 mg/mL) For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE 10 x 20 mL Single-Use Vial Rx only zydus pharmaceuticals figure02 figure03 figure04 figure05

Drug section

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