Esomeprazole Magnesium (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg — 30’s count

esomeprazole20mg
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Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg — 30’s count

esomeprazole40mg
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ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-572
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
GLYCERYL MONOSTEARATE
HYPROMELLOSES
MEGLUMINE
METHACRYLIC ACID
METHYL ALCOHOL
METHYLENE CHLORIDE
POLOXAMER 188
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
TALC
TRIETHYL CITRATE
GELATIN
FD&C BLUE NO. 1
TITANIUM DIOXIDE
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERRIC OXIDE YELLOW
SHELLAC
Product Characteristics
Color blue (Blue opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code H;72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-572-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:31722-572-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:31722-572-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202784 09/21/2015
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-573
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
GLYCERYL MONOSTEARATE
HYPROMELLOSES
MEGLUMINE
METHACRYLIC ACID
METHYL ALCOHOL
METHYLENE CHLORIDE
POLOXAMER 188
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
TALC
TRIETHYL CITRATE
GELATIN
FD&C BLUE NO. 1
TITANIUM DIOXIDE
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERRIC OXIDE YELLOW
SHELLAC
Product Characteristics
Color blue (Blue opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code H;71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-573-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:31722-573-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:31722-573-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202784 09/21/2015
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit III 676162024 analysis (31722-572), analysis (31722-573), manufacture (31722-572), manufacture (31722-573)

Revised: 06/2021 Camber Pharmaceuticals, Inc.

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