Omeprazole

OMEPRAZOLE- omeprazole capsule, delayed release
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-759-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 10 mg

Rx only

100 Capsules

Omeprazole DR Capsules, 10 mg
(click image for full-size original)

NDC 65841-760-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 20 mg

Rx only

100 Capsules

Omeprazole DR Capsules, 20 mg
(click image for full-size original)

NDC 65841-761-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 40 mg

Rx only

100 Capsules

Omeprazole DR Capsules, 40 mg
(click image for full-size original)
OMEPRAZOLE
omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-759
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
ACETONE
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 3
FERROSOFERRIC OXIDE
GELATIN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color PURPLE (AMETHYST PURPLE) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 10mm
Flavor Imprint Code ZA;09;10mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-759-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:65841-759-16 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:65841-759-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:65841-759-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
5 NDC:65841-759-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091352 11/23/2012
OMEPRAZOLE
omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-760
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
ACETONE
FD&C BLUE NO. 1
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BROWN (TAN) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 11mm
Flavor Imprint Code ZA;10;20mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-760-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:65841-760-16 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:65841-760-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:65841-760-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
5 NDC:65841-760-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091352 11/23/2012
OMEPRAZOLE
omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-761
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
ACETONE
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 3
FERROSOFERRIC OXIDE
GELATIN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color PURPLE (AMETHYST PURPLE) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code ZA;11;40mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-761-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:65841-761-16 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:65841-761-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:65841-761-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
5 NDC:65841-761-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091352 11/23/2012
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (65841-759), ANALYSIS (65841-760), ANALYSIS (65841-761), MANUFACTURE (65841-759), MANUFACTURE (65841-760), MANUFACTURE (65841-761)

Revised: 09/2023 Zydus Lifesciences Limited

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