ACYCLOVIR - acyclovir injection, solution 
Cadila Healthcare Limited

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Acyclovir Sodium Injection

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

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

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

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
ACYCLOVIR 
acyclovir injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1383
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1383-610 in 1 CARTON11/27/2018
1NDC:70771-1383-110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653511/27/2018
ACYCLOVIR 
acyclovir injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1384
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1384-610 in 1 CARTON11/27/2018
1NDC:70771-1384-120 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653511/27/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1383, 70771-1384) , MANUFACTURE(70771-1383, 70771-1384)

Revised: 11/2021
Document Id: abec93b4-7f31-43dc-a701-cc63f555d8fe
Set id: 383b930b-6e9c-4ac9-a078-baac6276f340
Version: 5
Effective Time: 20211129
 
Cadila Healthcare Limited