Label: PRUCALOPRIDE tablet, film coated
- NDC Code(s): 70771-1899-3, 70771-1900-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 30, 2026
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INGREDIENTS AND APPEARANCE
PRUCALOPRIDE
prucalopride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1899 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRUCALOPRIDE SUCCINATE (UNII: 4V2G75E1CK) (PRUCALOPRIDE - UNII:0A09IUW5TP) PRUCALOPRIDE 1 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color WHITE (Off-white) Score no score Shape ROUND (Round) Size 6mm Flavor Imprint Code 1753 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1899-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/02/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218056 02/02/2026 PRUCALOPRIDE
prucalopride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1900 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRUCALOPRIDE SUCCINATE (UNII: 4V2G75E1CK) (PRUCALOPRIDE - UNII:0A09IUW5TP) PRUCALOPRIDE 2 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color YELLOW (Light Yellow) Score no score Shape ROUND (Round) Size 9mm Flavor Imprint Code 1754 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1900-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/02/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218056 02/02/2026 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1899, 70771-1900) , MANUFACTURE(70771-1899, 70771-1900)
