Label: DEFERASIROX tablet, for suspension
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NDC Code(s):
70771-1409-1,
70771-1409-3,
70771-1409-9,
70771-1410-1, view more70771-1410-3, 70771-1410-9, 70771-1411-1, 70771-1411-3, 70771-1411-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 21, 2023
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INGREDIENTS AND APPEARANCE
DEFERASIROX
deferasirox tablet, for suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1409 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX 125 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code 1011 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1409-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 2 NDC:70771-1409-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 3 NDC:70771-1409-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208882 05/06/2021 DEFERASIROX
deferasirox tablet, for suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1410 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX 250 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape ROUND (ROUND) Size 15mm Flavor Imprint Code 1012 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1410-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 2 NDC:70771-1410-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 3 NDC:70771-1410-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208882 05/06/2021 DEFERASIROX
deferasirox tablet, for suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1411 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX 500 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape ROUND (ROUND) Size 18mm Flavor Imprint Code 1013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1411-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 2 NDC:70771-1411-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 3 NDC:70771-1411-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208882 05/06/2021 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1409, 70771-1410, 70771-1411) , MANUFACTURE(70771-1409, 70771-1410, 70771-1411)
