ESOMEPRAZOLE MAGNESIUM granule, delayed release

Esomeprazole Magnesium by

Drug Labeling and Warnings

Esomeprazole Magnesium by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC: 70771-1391-1

20 mg packet

Rx Only

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC: 70771-1391-3 unit dose packages of 30: 20 mg packets

Rx Only

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC: 70771-1392-1

40 mg packet

Rx Only

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC: 70771-1392-3 unit dose packages of 30: 40 mg packets

Rx Only

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium granule, delayed release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1391
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CROSPOVIDONE (UNII: 2S7830E561)
DEXTROSE (UNII: IY9XDZ35W2)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STRAWBERRY (UNII: 4J2TY8Y81V)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BROWN (WHITE TO PALE BROWN) , RED (PALE RED TO RED)	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1391-3	30 in 1 CARTON; Type 0: Not a Combination Product	06/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206055	06/30/2023

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium granule, delayed release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1392
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	40 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CROSPOVIDONE (UNII: 2S7830E561)
DEXTROSE (UNII: IY9XDZ35W2)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE (TYPE E) (UNII: 66O7AQV0RT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STRAWBERRY (UNII: 4J2TY8Y81V)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BROWN (WHITE TO PALE BROWN) , RED (PALE RED TO RED)	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1392-3	30 in 1 CARTON; Type 0: Not a Combination Product	06/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206055	06/30/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1391, 70771-1392) , MANUFACTURE(70771-1391, 70771-1392)