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NDC 51660-0061-44 Omeprazole 20.6 mg/1 Details

Omeprazole 20.6 mg/1

Omeprazole is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories Inc.. The primary component is OMEPRAZOLE MAGNESIUM.

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: 51660-0061-44
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Omeprazole

Product Information

NDC	51660-0061
Product ID	51660-061_0ae27ef3-b66f-469b-a0de-6cdd0a3a3a3f
Associated GPIs	49270060106520
GCN Sequence Number	066403
GCN Sequence Number Description	omeprazole magnesium CAPSULE DR 20 MG ORAL
HIC3	D4J
HIC3 Description	PROTON-PUMP INHIBITORS
GCN	28664
HICL Sequence Number	011115
HICL Sequence Number Description	OMEPRAZOLE MAGNESIUM
Brand/Generic	Generic
Proprietary Name	Omeprazole
Proprietary Name Suffix	n/a
Non-Proprietary Name	Omeprazole
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	20.6
Active Ingredient Units	mg/1
Substance Name	OMEPRAZOLE MAGNESIUM
Labeler Name	Ohm Laboratories 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	ANDA210593
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51660-0061-44 (51660006144)

Pricing Information
NDC Package Code	51660-061-44
Billing NDC	51660006144
Package	3 BOTTLE in 1 CARTON (51660-061-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date	2018-07-21
NDC Exclude Flag	N
Price Per Unit	0.38684
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	OMEPRAZOLE MAG DR 20 MG CAP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4c6b6230-ad1f-478c-b69e-aef27ecf61e9 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

*Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)

Purpose

Acid reducer

Use

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 omeprazole

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 reducers 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

for adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for 14 days
it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

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
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew or crush capsules.
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. 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). [See USP controlled room temperature]. Protect from moisture

Inactive ingredients

FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

Questions?

Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984.

SPL UNCLASSIFIED SECTION

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

†Compare To

the active ingredient of

Prilosec OTC®

NDC 51660-061-27

2x14 COUNT BOTTLE INSIDE

Treats FREQUENT Heartburn!

24

HR

Omeprazole

Delayed-release Capsules

20 mg* / Acid Reducer

ohm®

28 CAPSULES

Two 14-day courses of treatment

May take 1 to 4 days for full effect

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

INGREDIENTS AND APPEARANCE

OMEPRAZOLE

omeprazole capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-061
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20.6 mg

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	RG;49
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-061-44	3 in 1 CARTON	07/21/2018
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51660-061-27	2 in 1 CARTON	07/21/2018
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:51660-061-14	1 in 1 CARTON	07/21/2018
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	ANDA210593	07/21/2018

Labeler - Ohm Laboratories Inc. (184769029)

Registrant - Ohm Laboratories Inc. (184769029)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(51660-061)

Name	Address	ID/FEI	Business Operations
Establishment
Srini Pharmaceuticals Private Limited		725914795	API MANUFACTURE(51660-061)

Revised: 5/2019

Document Id: 0ae27ef3-b66f-469b-a0de-6cdd0a3a3a3f

Set id: 4c6b6230-ad1f-478c-b69e-aef27ecf61e9

Version: 3

Effective Time: 20190507

Search by Drug Name or NDC

NDC 51660-0061-44 Omeprazole 20.6 mg/1 Details

Omeprazole 20.6 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51660-0061-44 (51660006144)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4c6b6230-ad1f-478c-b69e-aef27ecf61e9 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each capsule)

Purpose

Use

Warnings

Allergy alert

Do not use if you have

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

INGREDIENTS AND APPEARANCE

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