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NDC 62756-0377-96 Omeprazole 20 mg/1 Details

Omeprazole 20 mg/1

Omeprazole is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, 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: 62756-0377-96
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Omeprazole

Product Information

NDC	62756-0377
Product ID	62756-377_f6cedf31-0870-404f-991f-20412238e74f
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 OTC DRUG
Dosage Form	TABLET, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/1
Substance Name	OMEPRAZOLE
Labeler Name	Sun Pharmaceutical Industries, 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	ANDA207891
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62756-0377-96 (62756037796)

Pricing Information	N/A
NDC Package Code	62756-377-96
Billing NDC	62756037796
Package	2 BLISTER PACK in 1 CARTON (62756-377-96) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 51c3ef34-b7c1-419e-a784-ae82540c7a22 Details

Active ingredient(in each tablet)

Omeprazole USP 20 mg

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

• omeprazole may cause severe skin reactions. Symptoms may include:

• skin reddening • blisters • rash

If an allergic reaction occurs, stop use and seek medical help right away.

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

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 to 25° C (68 to 77° F) and protect from moisture

Inactive ingredients

anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate.

The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

Questions or Comments?

Call toll free 1-800-818-4555 weekdays.

Tips of Managing Heartburn

Do not lie flat or bend over after eating
Do not wear tight-fitting clothing around the stomach
Do not eat before bedtime
Raise the head of your bed
Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
Eat slowly and avoid big meals
If overweight, lose weight
Quit smoking

Principal Display Panel - Foil

62756-377-40

Omeprazole Delayed-release Tablet

20 mg

Acid reducer

PUSH THROUGH

Mfg. by: Sun Pharmaceutical Ind Ltd., India.

Dist. by: Sun Pharmaceutical Ind Inc., NJ 08512

PGPF0520

Principal Display Panel - Blister Carton

NDC 62756-377-96

Compare to Prilosec OTC ® *

Treats Frequent Heartburn! (24 HR)

Compare to Prilosec OTC ® *

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

SWALLOW - DO NOT CHEW

28 (2 x 14) Unit-Dose Tablets

TWO 14-DAY COURSES OF TREATMENT

May take 1 to 4 days for full effect

Principal Display Panel - Label

NDC 62756-377-21

TreatsFrequentHeartburn! (24 HR)

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

14 Tablets

ONE 14-DAY COURSE OF TREATMENT

May take 1 to 4 days for full effect

Principal Display Panel - Bottle Carton

NDC 62756-377-11

Compare to Prilosec OTC ® *

Treats Frequent Heartburn! (24 HR)

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

SWALLOW - DO NOT CHEW

28 Tablets

TWO 14-DAY COURSES OF TREATMENT

May take 1 to 4 days for full effect

INGREDIENTS AND APPEARANCE

OMEPRAZOLE

omeprazole tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62756-377
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MONOETHANOLAMINE (UNII: 5KV86114PT)
METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
AMMONIA (UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	BROWN (brownish pink)	Score	no score
Shape	OVAL (biconvex)	Size	12mm
Flavor		Imprint Code	20
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62756-377-21	1 in 1 CARTON	01/01/2019
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:62756-377-11	2 in 1 CARTON	01/01/2019
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:62756-377-12	3 in 1 CARTON	01/01/2019
3		14 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:62756-377-70	1 in 1 CARTON	01/01/2019
4		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:62756-377-96	2 in 1 CARTON	01/01/2019
5		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:62756-377-79	3 in 1 CARTON	01/01/2019
6		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207891	01/01/2019

Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Pharmaceutical Industries Limited		650445203	ANALYSIS(62756-377) , MANUFACTURE(62756-377)

Revised: 11/2022

Document Id: f6cedf31-0870-404f-991f-20412238e74f

Set id: 51c3ef34-b7c1-419e-a784-ae82540c7a22

Version: 4

Effective Time: 20221104