Label: SEVELAMER CARBONATE tablet, film coated
- NDC Code(s): 70771-1520-0, 70771-1520-2, 70771-1520-4, 70771-1520-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
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INGREDIENTS AND APPEARANCE
SEVELAMER CARBONATE
sevelamer carbonate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1520 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SEVELAMER CARBONATE (UNII: 9YCX42I8IU) (SEVELAMER - UNII:941N5DUU5C) SEVELAMER CARBONATE 800 mg Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) DIBUTYL SEBACATE (UNII: 4W5IH7FLNY) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIACETIN (UNII: XHX3C3X673) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (off-white to pale yellow) Score no score Shape CAPSULE (MODIFIED CAPSULE) Size 20mm Flavor Imprint Code 824 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1520-8 270 in 1 BOTTLE; Type 0: Not a Combination Product 09/17/2020 2 NDC:70771-1520-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/17/2020 3 NDC:70771-1520-4 10 in 1 CARTON 09/17/2020 3 NDC:70771-1520-2 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 ANDA207759 09/17/2020 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1520) , MANUFACTURE(70771-1520)
