Acyclovir Injection, Solution
FDA Label NDC 70771-1384

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Acyclovir (NDC 70771-1384). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

 

Figure02 (F6f60d2d E059 4ab1 90ce 047717607506 02)

Figure02 (F6f60d2d E059 4ab1 90ce 047717607506 02)

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

Figure03 (F6f60d2d E059 4ab1 90ce 047717607506 03)

Figure03 (F6f60d2d E059 4ab1 90ce 047717607506 03)

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

 

Figure04 (F6f60d2d E059 4ab1 90ce 047717607506 04)

Figure04 (F6f60d2d E059 4ab1 90ce 047717607506 04)

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

Figure05 (F6f60d2d E059 4ab1 90ce 047717607506 05)

Figure05 (F6f60d2d E059 4ab1 90ce 047717607506 05)

* Please review the disclaimer below.