Acyclovir Sodium Injection

Acyclovir Sodium Injection
SPL v6
SPL
SPL Set ID 383b930b-6e9c-4ac9-a078-baac6276f340
Route
INTRAVENOUS
Published
Effective Date 2020-10-13
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acyclovir (50 mg)
Inactive Ingredients
Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2018-11-27

Description

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


Medication Information

Description

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

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


Structured Label Content

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


Advanced Ingredient Data


Raw Label Data

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