Esomeprazole Magnesium: Package Insert and Label Information (Page 7 of 7)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 20 mg 30 Capsules

NDC 69844-031 -01

Esomeprazole Magnesium Delayed-Release Capsules, USP

20 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

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(click image for full-size original)

NDC 69844-032 -01

Esomeprazole Magnesium Delayed-Release Capsules, USP

40 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

image
(click image for full-size original)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
GELATIN
GLYCERYL MONO AND DIPALMITOSTEARATE
HYDROXYPROPYL CELLULOSE (110000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYSORBATE 80
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (white opaque cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 186;20;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-031-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:69844-031-02 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:69844-031-03 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213486 03/19/2021
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
GELATIN
GLYCERYL MONO AND DIPALMITOSTEARATE
HYDROXYPROPYL CELLULOSE (110000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYSORBATE 80
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (white opaque cap) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 187;40;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-032-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:69844-032-02 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:69844-032-03 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213486 03/19/2021
Labeler — Graviti Pharmaceuticals Private Limited (650884781)
Registrant — Graviti Pharmaceuticals Private Limited (650884781)
Establishment
Name Address ID/FEI Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE (69844-031), MANUFACTURE (69844-032), ANALYSIS (69844-031), ANALYSIS (69844-032)

Revised: 03/2022 Graviti Pharmaceuticals Private Limited

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