Omeprazole (Page 9 of 9)

15 REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically—Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol, 20, No. 2, NCCLS, Wayne, PA, January 2000.

16 HOW SUPPLIED/STORAGE AND HANDLING

Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg

and body ‘R157’ with black ink. The capsules are supplied in bottles of 60 and 120.

Bottles of 60 NDC 42254-043-60

Bottles of 120 NDC 42254-043-72

Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mg

and body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 10 x 10.

Bottles of 7 NDC 42254-053-07

Bottles of 14 NDC 42254-053-14

Bottles of 30 NDC 42254-053-30

Bottles of 60 NDC 42254-053-60

Bottles of 90 NDC 42254-053-90

Bottles of 120 NDC 42254-053-72

Storage

Store delayed-release capsules in a tight container protected from light and moisture.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Omeprazole delayed-release capsules should be taken before eating. Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA

Issued:0109

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

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

Principal Display Panel

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

OMEPRAZOLE
omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-043(NDC:55111-157)
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
crospovidone
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLOXAMER 124
POVIDONE
TRIETHYL CITRATE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
GELATIN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
BUTYL ALCOHOL
SHELLAC
PROPYLENE GLYCOL
ALCOHOL
FERROSOFERRIC OXIDE
Product Characteristics
Color white (off-white to pale yellow) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Omeprazole;10;mg;R;157
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-043-60 60 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
2 NDC:42254-043-72 120 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075576 10/22/2007
OMEPRAZOLE
omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-053(NDC:55111-158)
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
crospovidone
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLOXAMER 124
POVIDONE
TRIETHYL CITRATE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
GELATIN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
BUTYL ALCOHOL
SHELLAC
PROPYLENE GLYCOL
ALCOHOL
FERROSOFERRIC OXIDE
Product Characteristics
Color white (off-white to pale yellow) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Omeprazole;20;mg;R;158
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-053-14 14 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
2 NDC:42254-053-60 60 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
3 NDC:42254-053-90 90 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
4 NDC:42254-053-72 120 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
5 NDC:42254-053-07 7 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
6 NDC:42254-053-30 30 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075576 10/22/2007
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 12/2011 Rebel Distributors Corp

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