Lansoprazole

LANSOPRAZOLE- lansoprazole capsule, delayed release pellets
Cadila Healthcare Limited

Manufactured by:

Cadila Healthcare Ltd.

India.

NDC 65841-769-10 in bottle of 1000 Capsules

Lansoprazole Delayed-release Capsules USP, 15 mg

Rx only

1000 Capsules

Structured formula for lansoprazole
(click image for full-size original)

NDC 65841-770-10 in bottle of 1000 Capsules

Lansoprazole Delayed-release Capsules USP, 30 mg

Rx only

1000 Capsules

Structured formula for lansoprazole
(click image for full-size original)
LANSOPRAZOLE
lansoprazole capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-769
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 15 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
AMMONIA
BUTYL ALCOHOL
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
ISOPROPYL ALCOHOL
SHELLAC
MAGNESIUM CARBONATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
GELATIN
SUCROSE
TALC
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
STARCH, CORN
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 Multilevel Packaging
1 NDC:65841-769-06 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
2 NDC:65841-769-10 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
3 NDC:65841-769-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK This package is contained within the CARTON (65841-769-30)
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 pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-770
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 30 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
AMMONIA
BUTYL ALCOHOL
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
ISOPROPYL ALCOHOL
SHELLAC
MAGNESIUM CARBONATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
GELATIN
SUCROSE
TALC
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
STARCH, CORN
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 Multilevel Packaging
1 NDC:65841-770-06 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
2 NDC:65841-770-16 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
3 NDC:65841-770-01 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
4 NDC:65841-770-10 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
5 NDC:65841-770-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK This package is contained within the CARTON (65841-770-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202366 08/23/2013
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-769), ANALYSIS (65841-770), MANUFACTURE (65841-769), MANUFACTURE (65841-770)

Revised: 08/2020 Cadila Healthcare Limited

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