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NDC 49035-0980-08 Esomeprazole Magnesium 20 mg/1 Details

Esomeprazole Magnesium 20 mg/1

Esomeprazole Magnesium is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is ESOMEPRAZOLE MAGNESIUM DIHYDRATE.

MedlinePlus Drug Summary

Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine) in adults. It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Prescription esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Nonprescription (over-the-counter) esomeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Related Packages: 49035-0980-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Esomeprazole

Product Information

NDC	49035-0980
Product ID	49035-980_c29c11ae-2ff7-4653-9dd8-d25175cb9201
Associated GPIs	49270025106520
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Esomeprazole Magnesium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Esomeprazole Magnesium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/1
Substance Name	ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Labeler Name	Wal-Mart Stores, Inc.
Pharmaceutical Class	Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209339
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0980-08 (49035098008)

Pricing Information	N/A
NDC Package Code	49035-980-08
Billing NDC	49035098008
Package	2 BOTTLE in 1 CARTON (49035-980-08) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date	2017-10-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c14f096d-ea1f-4539-8ad0-bb9907745cfc Details

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

Uses

treats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

Do not use if you have:

trouble or pain swallowing food, vomiting with blood, or bloody or black stools
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

had heartburn over 3 months. This may be a sign of a more serious condition.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reduces may interact with certain prescription drugs.

Stop use and ask a doctor if

your heartburn continues or worsens
you need to take this product for more than 14 days
you need to take more than 1 course of treatment every 4 months
you get diarrhea
you develop a rash or joint pain

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for 14 days
may take 1 to 4 days for full effect

14-Day Course of Treatment

swallow 1 capsule with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
swallow whole. Do not crush or chew capsules.
do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

you may repeat a 14-day course every 4 months
do not take for more than 14 days or more often than every 4 months unless directed by a doctor
children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

read the directions and warnings before use
keep the carton. It contains important information.
store at 20-25°C (68-77°F)
Meets USP dissolution test 2

Inactive ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and diglycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.

Questions or comments?

call 1-888-287-1915

DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF INDIA

TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)

equate™

NDC 49035-980-05

24 HOURS

Esomeprazole Magnesium

Delayed-Release Capsules USP, 20 mg*

Acid Reducer

Treats Frequent Heartburn

• May take 1 to 4 days for full effect

14 CAPSULES

One 14-day course

of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

SEE NEW WARNING INFORMATION

NDC 49035-980-05

equate™

Compare to Nexium® 24 HR active ingredient**

Esomeprazole Magnesium

Delayed-Release Capsules USP, 20 mg*

Acid Reducer

24 HOURS

Treats Frequent Heartburn

• May take 1 to 4 days for full effect

Actual Size

14 CAPSULES

One 14-day course of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsule Container Carton)

SEE NEW WARNING INFORMATION

NDC 49035-980-08

equate™

Compare to Nexium® 24 HR active ingredient**

Esomeprazole Magnesium

Delayed-Release Capsules USP, 20 mg*

Acid Reducer

24 HOURS

Treats Frequent Heartburn

• May take 1 to 4 days for full effect

Actual Size

28 CAPSULES

Two 14-day courses of treatment

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM

esomeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-980
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
AMMONIA (UNII: 5138Q19F1X)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	I81
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-980-05	1 in 1 CARTON	10/16/2017
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49035-980-08	2 in 1 CARTON	10/16/2017
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:49035-980-10	3 in 1 CARTON	10/16/2017
3		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209339	10/16/2017

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(49035-980) , MANUFACTURE(49035-980)

Revised: 9/2021

Document Id: c29c11ae-2ff7-4653-9dd8-d25175cb9201

Set id: c14f096d-ea1f-4539-8ad0-bb9907745cfc

Version: 6

Effective Time: 20210927