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NDC 53002-1688-00 Omeprazole 40 mg/1 Details

Omeprazole 40 mg/1

Omeprazole is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is OMEPRAZOLE.

MedlinePlus Drug Summary

Prescription omeprazole is used alone or with other medications 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 omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Related Packages: 53002-1688-00
Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Omeprazole

Product Information

NDC	53002-1688
Product ID	53002-1688_feff0609-4c4f-4399-a046-f07e4469822c
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	Omeprazole
Proprietary Name Suffix	n/a
Non-Proprietary Name	Omeprazole
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	40
Active Ingredient Units	mg/1
Substance Name	OMEPRAZOLE
Labeler Name	RPK Pharmaceuticals, 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	ANDA091672
Listing Certified Through	2024-12-31

Package

NDC 53002-1688-00 (53002168800)

Pricing Information	N/A
NDC Package Code	53002-1688-0
Billing NDC	53002168800
Package	100 CAPSULE, DELAYED RELEASE in 1 POUCH (53002-1688-0)
Marketing Start Date	2017-09-01
NDC Exclude Flag	N