Omeprazole Magnesium

Manufacturer: Gericare Pharmaceuticals
Effective date: 2025-07-28
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:08:49

Label at a glance#

ProductOmeprazole Magnesium

Active ingredientOMEPRAZOLE MAGNESIUM

Label structure9 sections

Indications and 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

Dosage and administration

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 ...

Storage and handling

read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) and protect from moisture

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

*Omeprazole delayed-release capsules 20 mg
(equivalent to 20.6 mg omeprazole magnesium)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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:

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

read the directions and warnings before use
keep the carton. It contains important information.
store at 20-25°C (68-77°F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions?

OTC - QUESTIONS SECTION

call 1-888-375-3784

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	7
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	7
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OMEPRAZOLE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57896-759-14	Omeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	7
57896-759-14	Omeprazole Magnesium	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	7
57896-759-28	Omeprazole Magnesium	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	7
57896-759-28	Omeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	7
57896-759-42	Omeprazole Magnesium	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	7
57896-759-42	Omeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-759-28	EA - Each	57896-759	dc2738a4-458f-4026-8e70-1f781eb7a895	1	2019-04-11
57896-759-42	EA - Each	57896-759	34877fb4-b1fe-4384-bbcc-e842615f3d52	1	2018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	426QFE7XLK	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
RAW SUGAR	INACTIVE INGREDIENT	8M707QY5GH	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

Omeprazole Magnesium
MAGNESIUM OXIDE
MAGNESIUM STEARATE
RAW SUGAR
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
GLYCERYL MONOSTEARATE
HYPROMELLOSE 2208 (3 MPA.S)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)
GELATIN
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
FERRIC OXIDE RED
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
OMEPRAZOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57896-759	57896-759-14, 57896-759-28, 57896-759-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM OXIDE	3A3U0GI71G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
RAW SUGAR	8M707QY5GH	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
HYPROMELLOSE 2208 (3 MPA.S)	9H4L916OBU	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	5KY68S2577	IACT
GELATIN	2G86QN327L	IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
SHELLAC	46N107B71O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
OMEPRAZOLE MAGNESIUM	426QFE7XLK	ACTIM

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 116 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL		360 mg	Exact identifier — unii+route 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, DELAYED RELEASE / ORAL		1321 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, DELAYED RELEASE / ORAL		2834 mg	Exact identifier — unii+route 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSE 2208 (3 MPA.S)	HYPROMELLOSE 2208 (3 MPA.S)	9H4L916OBU	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, DELAYED RELEASE / ORAL		2834 mg	Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE, EXTENDED RELEASE / ORAL	301.7 mg		Exact identifier — unii+route 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE / ORAL	401 mg		Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	PASTILLE / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL		360 mg	Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FOR SUSPENSION / ORAL		406 mg	Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FOR SUSPENSION / ORAL		406 mg	Exact identifier — unii+route 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	5KY68S2577	CAPSULE, DELAYED RELEASE / ORAL		107 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE, EXTENDED RELEASE / ORAL	301.7 mg		Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	5KY68S2577	CAPSULE, DELAYED RELEASE / ORAL		107 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSE 2208 (3 MPA.S)	HYPROMELLOSE 2208 (3 MPA.S)	9H4L916OBU	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, DELAYED RELEASE / ORAL		2834 mg	Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE, EXTENDED RELEASE / ORAL	301.7 mg		Exact identifier — unii+route 40 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, COATED / ORAL	333.3 mg		Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route 40 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL		360 mg	Exact identifier — unii+route 40 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	5KY68S2577	CAPSULE, DELAYED RELEASE / ORAL		107 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, COATED / ORAL	333.3 mg		Exact identifier — unii+route 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, DELAYED RELEASE / ORAL		1321 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route 40 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, DELAYED RELEASE / ORAL		1321 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, CHEWABLE / ORAL	50 mg		Exact identifier — unii+route 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, CHEWABLE / ORAL	50 mg		Exact identifier — unii+route 40 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078878-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RS	2009-06-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Gericare Pharmaceuticals	0e1f5d7c-5956-3be7-e054-00144ff8d46c	2025-07-28	Warnings	Exact identifier ndc (package): 57896-759-14 ndc (package): 57896-759-42 ndc (package): 57896-759-28 ndc (product): 57896-759 ndc11 (package): 57896075942 ndc11 (package): 57896075914 ndc11 (package): 57896075928 spl id: 3b0207de-ac3b-e214-e063-6294a90a59fc spl set id: 0e1f5d7c-5956-3be7-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.