Label: DIPYRIDAMOLE tablet, film coated
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NDC Code(s):
65841-662-01,
65841-662-05,
65841-662-10,
65841-662-77, view more65841-663-01, 65841-663-05, 65841-663-10, 65841-663-77, 65841-664-01, 65841-664-05, 65841-664-10, 65841-664-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 25, 2022
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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPYRIDAMOLE
dipyridamole tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-662 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE 25 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZE;43 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-662-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 2 NDC:65841-662-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 3 NDC:65841-662-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 4 NDC:65841-662-77 10 in 1 CARTON 05/22/2008 4 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 ANDA040874 05/22/2008 DIPYRIDAMOLE
dipyridamole tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-663 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE 50 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code ZE;49 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-663-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 2 NDC:65841-663-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 3 NDC:65841-663-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 4 NDC:65841-663-77 10 in 1 CARTON 05/22/2008 4 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 ANDA040874 05/22/2008 DIPYRIDAMOLE
dipyridamole tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-664 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE 75 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZE;50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-664-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 2 NDC:65841-664-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 3 NDC:65841-664-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2008 4 NDC:65841-664-77 10 in 1 CARTON 05/22/2008 4 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 ANDA040874 05/22/2008 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-662, 65841-663, 65841-664) , MANUFACTURE(65841-662, 65841-663, 65841-664) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-662, 65841-663, 65841-664) , MANUFACTURE(65841-662, 65841-663, 65841-664)
