Label: ZONISAMIDE capsule
-
NDC Code(s):
70771-1142-1,
70771-1142-5,
70771-1143-1,
70771-1143-5, view more70771-1144-0, 70771-1144-1, 70771-1144-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated August 16, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- MEDICATION GUIDE
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZONISAMIDE
zonisamide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1142 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE 25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 (UNII: X3W0AM1JLX) GELATIN (UNII: 2G86QN327L) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (PINK) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code ZA;31;25;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1142-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 2 NDC:70771-1142-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077625 11/22/2017 ZONISAMIDE
zonisamide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1143 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE 50 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 (UNII: X3W0AM1JLX) GELATIN (UNII: 2G86QN327L) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (PINK) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code ZA;32;50;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1143-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 2 NDC:70771-1143-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077625 11/22/2017 ZONISAMIDE
zonisamide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1144 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE 100 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 (UNII: X3W0AM1JLX) GELATIN (UNII: 2G86QN327L) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (PINK) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code ZA;33;100;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1144-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 2 NDC:70771-1144-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 3 NDC:70771-1144-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077625 11/22/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1142, 70771-1143, 70771-1144) , MANUFACTURE(70771-1142, 70771-1143, 70771-1144)