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![ZIPRASIDONE CAPSULE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/d607e3c2-62f5-4f4c-bbb3-423ac9478420/6843260d-1554-49ec-ae89-473fd1b8543c-04.jpg)
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| NDC | 70771-1179-2, 70771-1179-5, 70771-1179-6, 70771-1179-8, 70771-1180-2, 70771-1180-5, 70771-1180-6, 70771-1180-8, 70771-1181-2, 70771-1181-5, 70771-1181-6, 70771-1181-8, 70771-1182-2, 70771-1182-5, 70771-1182-6, 70771-1182-8 |
| Set ID | d607e3c2-62f5-4f4c-bbb3-423ac9478420 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Atypical Antipsychotic |
| Product Number | |
| Application Number | ANDA208988 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZIPRASIDONE
ziprasidone capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1179 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE 20 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (DARK BLUE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code 237 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1179-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 2 NDC:70771-1179-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 3 NDC:70771-1179-8 8 in 1 CARTON 12/28/2017 3 NDC:70771-1179-2 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 ANDA208988 12/28/2017 ZIPRASIDONE
ziprasidone capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1180 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE 80 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (DARK BLUE OPAQUE CAP) , BLUE (LIGHT BLUE OPAQUE BODY) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 240 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1180-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 2 NDC:70771-1180-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 3 NDC:70771-1180-8 8 in 1 CARTON 12/28/2017 3 NDC:70771-1180-2 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 ANDA208988 12/28/2017 ZIPRASIDONE
ziprasidone capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1181 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE 60 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code 239 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1181-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 2 NDC:70771-1181-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 3 NDC:70771-1181-8 8 in 1 CARTON 12/28/2017 3 NDC:70771-1181-2 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 ANDA208988 12/28/2017 ZIPRASIDONE
ziprasidone capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1182 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE 40 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (DARK BLUE OPAQUE CAP) , BLUE (LIGHT BLUE OPAQUE BODY) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code 238 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1182-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 2 NDC:70771-1182-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 3 NDC:70771-1182-8 8 in 1 CARTON 12/28/2017 3 NDC:70771-1182-2 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 ANDA208988 12/28/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1179, 70771-1180, 70771-1181, 70771-1182) , MANUFACTURE(70771-1179, 70771-1180, 70771-1181, 70771-1182)
