Label: ACYCLOVIR injection, solution
- NDC Code(s): 70771-1383-1, 70771-1383-6, 70771-1384-1, 70771-1384-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
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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
-
INGREDIENTS AND APPEARANCE
ACYCLOVIR
acyclovir injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1383 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1383-6 10 in 1 CARTON 11/27/2018 1 NDC:70771-1383-1 10 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206535 11/27/2018 ACYCLOVIR
acyclovir injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1384 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1384-6 10 in 1 CARTON 11/27/2018 1 NDC:70771-1384-1 20 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206535 11/27/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1383, 70771-1384) , MANUFACTURE(70771-1383, 70771-1384)