![VALACYCLOVIR TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/91832fd8-0d76-4408-9d26-9d5f52c47670/55e13be0-e657-4ac6-b274-a353371467fe-02.jpg)
![VALACYCLOVIR TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/91832fd8-0d76-4408-9d26-9d5f52c47670/55e13be0-e657-4ac6-b274-a353371467fe-03.jpg)
| NDC | 65841-629-01, 65841-629-06, 65841-629-10, 65841-629-30, 65841-629-77, 65841-630-06, 65841-630-10, 65841-630-34 |
| Set ID | 91832fd8-0d76-4408-9d26-9d5f52c47670 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA079137 |
- 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 - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-629, 65841-630) , MANUFACTURE(65841-629, 65841-630)
