Label: LURASIDONE HYDROCHLORIDE tablet, coated
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NDC Code(s):
70771-1734-1,
70771-1734-2,
70771-1734-3,
70771-1734-4, view more70771-1734-5, 70771-1734-9, 70771-1735-1, 70771-1735-2, 70771-1735-3, 70771-1735-4, 70771-1735-5, 70771-1735-9, 70771-1736-1, 70771-1736-2, 70771-1736-3, 70771-1736-4, 70771-1736-5, 70771-1736-9, 70771-1737-1, 70771-1737-2, 70771-1737-3, 70771-1737-4, 70771-1737-5, 70771-1737-9, 70771-1738-1, 70771-1738-2, 70771-1738-3, 70771-1738-4, 70771-1738-5, 70771-1738-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1734 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE 20 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (YELLOW TO LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code C31 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1734-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:70771-1734-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:70771-1734-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 4 NDC:70771-1734-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 5 NDC:70771-1734-4 10 in 1 CARTON 02/01/2023 5 NDC:70771-1734-2 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 ANDA208052 02/01/2023 LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1735 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE 40 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code C32 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1735-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:70771-1735-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:70771-1735-4 10 in 1 CARTON 02/01/2023 3 NDC:70771-1735-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:70771-1735-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 5 NDC:70771-1735-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208052 02/01/2023 LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1736 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape CAPSULE (MODIFIED CAPSULE) Size 13mm Flavor Imprint Code C33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1736-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:70771-1736-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:70771-1736-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 4 NDC:70771-1736-4 10 in 1 CARTON 02/01/2023 4 NDC:70771-1736-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:70771-1736-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208052 02/01/2023 LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1737 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE 80 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (YELLOW TO LIGHT YELLOW) Score no score Shape OVAL (OVAL) Size 12mm Flavor Imprint Code C34 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1737-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:70771-1737-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:70771-1737-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 4 NDC:70771-1737-4 10 in 1 CARTON 02/01/2023 4 NDC:70771-1737-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:70771-1737-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208052 02/01/2023 LURASIDONE HYDROCHLORIDE
lurasidone hydrochloride tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1738 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) POLOXAMER 407 (UNII: TUF2IVW3M2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape OVAL (OVAL) Size 15mm Flavor Imprint Code C35 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1738-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:70771-1738-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:70771-1738-4 10 in 1 CARTON 02/01/2023 3 NDC:70771-1738-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:70771-1738-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 5 NDC:70771-1738-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208052 02/01/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1734, 70771-1735, 70771-1736, 70771-1737, 70771-1738) , MANUFACTURE(70771-1734, 70771-1735, 70771-1736, 70771-1737, 70771-1738)
