Label: VALACYCLOVIR tablet, film coated
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NDC Code(s):
65841-629-01,
65841-629-06,
65841-629-10,
65841-629-30, view more65841-629-77, 65841-630-06, 65841-630-10, 65841-630-34
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VALACYCLOVIR
valacyclovir tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-629 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR 500 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE) Score no score Shape OVAL (CAPSULE) Size 18mm Flavor Imprint Code 500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-629-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 2 NDC:65841-629-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 3 NDC:65841-629-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 4 NDC:65841-629-77 10 in 1 CARTON 04/05/2018 4 NDC:65841-629-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079137 04/05/2018 VALACYCLOVIR
valacyclovir tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-630 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR 1000 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape OVAL (CAPSULE) Size 23mm Flavor Imprint Code 1000 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-630-34 21 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 2 NDC:65841-630-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 3 NDC:65841-630-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079137 04/05/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-629, 65841-630) , MANUFACTURE(65841-629, 65841-630)
