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| NDC | 70771-1142-1, 70771-1142-5, 70771-1143-1, 70771-1143-5, 70771-1144-0, 70771-1144-1, 70771-1144-5 |
| Set ID | 4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Anti-epileptic Agent |
| Product Number | |
| Application Number | ANDA077625 |
- MEDICATION GUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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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 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 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 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 - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1142, 70771-1143, 70771-1144) , MANUFACTURE(70771-1142, 70771-1143, 70771-1144)
