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NDC 65162-0645-50 Esomeprazole Magnesium 40 mg/1 Details

Esomeprazole Magnesium 40 mg/1

Esomeprazole Magnesium is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is ESOMEPRAZOLE MAGNESIUM.

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: 65162-0645-50
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Esomeprazole

Product Information

NDC	65162-0645
Product ID	65162-645_93959bc8-20a5-4cc2-b76a-f3e98056d1ae
Associated GPIs
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 PRESCRIPTION DRUG
Dosage Form	CAPSULE, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	40
Active Ingredient Units	mg/1
Substance Name	ESOMEPRAZOLE MAGNESIUM
Labeler Name	Amneal Pharmaceuticals LLC
Pharmaceutical Class	Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209647
Listing Certified Through	2025-12-31

Package

NDC 65162-0645-50 (65162064550)

Pricing Information	N/A
NDC Package Code	65162-645-50
Billing NDC	65162064550
Package	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-645-50)
Marketing Start Date	2019-04-10
NDC Exclude Flag	N