Label: ZIPRASIDONE capsule
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NDC Code(s):
70771-1179-2,
70771-1179-5,
70771-1179-6,
70771-1179-8, view more70771-1180-2, 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
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 4, 2023
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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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 - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1179, 70771-1180, 70771-1181, 70771-1182) , MANUFACTURE(70771-1179, 70771-1180, 70771-1181, 70771-1182)
