LANSOPRAZOLE- lansoprazole capsule, delayed release pellets 
Zydus Lifesciences Limited

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LANSOPRAZOLE DELAYED-RELEASE CAPSULES

Manufactured by:

Cadila Healthcare Ltd.

India.

SPL MEDGUIDE

NDC 65841-769-10 in bottle of 1000 Capsules

Lansoprazole Delayed-release Capsules USP, 15 mg

Rx only

1000 Capsules

Structured formula for lansoprazole

NDC 65841-770-10 in bottle of 1000 Capsules

Lansoprazole Delayed-release Capsules USP, 30 mg

Rx only

1000 Capsules

Structured formula for lansoprazole
LANSOPRAZOLE 
lansoprazole capsule, delayed release pellets
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-769
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (PINK) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code ZA;50;15mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-769-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/23/201303/25/2025
2NDC:65841-769-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/23/201303/25/2025
3NDC:65841-769-3010 in 1 CARTON08/23/201303/25/2025
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20236608/23/201304/26/2025
LANSOPRAZOLE 
lansoprazole capsule, delayed release pellets
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-770
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE30 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (PINK) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size20mm
FlavorImprint Code ZA;51;30mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-770-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/23/201303/25/2025
2NDC:65841-770-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/23/201303/25/2025
3NDC:65841-770-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/23/201303/25/2025
4NDC:65841-770-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/23/201303/25/2025
5NDC:65841-770-3010 in 1 CARTON08/23/201303/25/2025
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20236608/23/201304/26/2025
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-769, 65841-770) , MANUFACTURE(65841-769, 65841-770)

Revised: 4/2025
Document Id: fe950038-8731-4a27-b852-d816f3ca8f4a
Set id: 923f840f-4b78-40f3-ab53-760002637da5
Version: 10
Effective Time: 20250426
 
Zydus Lifesciences Limited