Label: ACYCLOVIR injection, powder, lyophilized, for solution
- NDC Code(s): 70771-1081-6, 70771-1082-6
- 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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- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
Acyclovir for Injection, USP 500 mg/vial - Vial Label
NDC 70771-1081-1
Acyclovir for Injection, USP
Equivalent to
500 mg/vial
acyclovir
For Intravenous Infusion Only
Rx only
zydus pharmaceuticals
Acyclovir for Injection, USP 500 mg/vial - Carton Label
NDC 70771-1081-6
Acyclovir for Injection, USP
Equivalent to
500 mg/vial
acyclovir
For Intravenous Infusion Only
10 x 500 mg vials
Rx only
zydus pharmaceuticals
Acyclovir for Injection, USP 1000 mg/vial - Vial Label
NDC 70771-1082-1
Acyclovir for Injection, USP
Equivalent to
1000 mg/vial
acyclovir
For Intravenous Infusion Only
Rx only
zydus pharmaceuticals
Acyclovir for Injection, USP 1000 mg/vial - Carton Label
NDC 70771-1082-6
Acyclovir for Injection, USP
Equivalent to
1000 mg/vial
acyclovir
For Intravenous Infusion Only
10 x 1000 mg vials
Rx only
zydus pharmaceuticals
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INGREDIENTS AND APPEARANCE
ACYCLOVIR
acyclovir injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1081 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR 500 mg 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:70771-1081-6 10 in 1 CARTON; Type 0: Not a Combination Product 08/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206606 08/17/2017 ACYCLOVIR
acyclovir injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1082 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR 1000 mg 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:70771-1082-6 10 in 1 CARTON; Type 0: Not a Combination Product 08/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206606 08/17/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1081, 70771-1082) , MANUFACTURE(70771-1081, 70771-1082)