Label: LANSOPRAZOLE capsule, delayed release pellets
-
NDC Code(s):
65841-769-06,
65841-769-10,
65841-769-30,
65841-770-01, view more65841-770-06, 65841-770-10, 65841-770-16, 65841-770-30
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 26, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- MEDICATION GUIDE
- SPL MEDGUIDE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole capsule, delayed release pelletsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-769 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 15 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) SHELLAC (UNII: 46N107B71O) MAGNESIUM CARBONATE (UNII: 0E53J927NA) METHACRYLIC ACID (UNII: 1CS02G8656) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (PINK) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code ZA;50;15mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-769-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2013 2 NDC:65841-769-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2013 3 NDC:65841-769-30 10 in 1 CARTON 08/23/2013 3 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 ANDA202366 08/23/2013 LANSOPRAZOLE
lansoprazole capsule, delayed release pelletsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-770 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 30 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) SHELLAC (UNII: 46N107B71O) MAGNESIUM CARBONATE (UNII: 0E53J927NA) METHACRYLIC ACID (UNII: 1CS02G8656) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (PINK) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 20mm Flavor Imprint Code ZA;51;30mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-770-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2013 2 NDC:65841-770-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2013 3 NDC:65841-770-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2013 4 NDC:65841-770-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2013 5 NDC:65841-770-30 10 in 1 CARTON 08/23/2013 5 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 ANDA202366 08/23/2013 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-769, 65841-770) , MANUFACTURE(65841-769, 65841-770)
