QUALITY CHOICE OMEPRAZOLE

Manufacturer: Chain Drug Marketing Association | Geri-Care Pharmaceutical Corp
Effective date: 2014-05-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:33

Label at a glance#

ProductQUALITY CHOICE OMEPRAZOLE

Active ingredientOMEPRAZOLE

Label structure8 sections

Dosage and administration

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, although 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 unle...

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) keep product out of high heat and humidity protect product from moisture

Contacts and useful links#

PhoneLabel contact1-800-540-3765

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole delayed-release tablet, 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

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

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. 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.
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
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Ask a doctor or pharmacist before use if you are taking

warfarin, clopidogrel or cilostazol (blood-thinning medicines)
prescription antifungal or anti-yeast medicines
diazepam (anxiety medicine)
digoxin (heart medicine)
tacrolimus (immune system medicine)
prescription antiretrovirals (medicines for HIV infection)

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

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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, although 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

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)
keep product out of high heat and humidity
protect product from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-540-3765

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63868-170-42

QUALITY CHOICE

Treats Frequent Heartburn!

Occurring 2 or more days a week

Omeprazole

Delayed Release Tablets, 20mg

Frequent Heartburn Relief

Acid Reducer

42 Tablets

Three 14-day courses of treatment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	1
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	1
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	1

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
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
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-170-42	2020-01-31	C162847	48780-1	9d75b9d0-732d-f424-e053-dadaa90a57ce	0022ca14-9177-4fe9-90f3-1d67592d8d6c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-170-42	QUALITY CHOICE OMEPRAZOLE	14 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	14		1
63868-170-42	QUALITY CHOICE OMEPRAZOLE	3 in 1 CARTON	TABLET, DELAYED RELEASE	3		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-170	QUALITY CHOICE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]	1	Legacy NDC, 2 package rows	20140617_0022ca14-9177-4fe9-90f3-1d67592d8d6c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)	INACTIVE INGREDIENT	36BGF0E889	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MONOETHANOLAMINE	INACTIVE INGREDIENT	5KV86114PT	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
SODIUM STEARATE	INACTIVE INGREDIENT	QU7E2XA9TG	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	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 · 17 matching rows.

QUALITY CHOICE OMEPRAZOLE
omeprazole
CARNAUBA WAX
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)
LACTOSE MONOHYDRATE
MONOETHANOLAMINE
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARATE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-170	63868-170-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OMEPRAZOLE	KG60484QX9	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)	36BGF0E889	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MONOETHANOLAMINE	5KV86114PT	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
SODIUM STEARATE	QU7E2XA9TG	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT

Source Document#

Source XML

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 6 · 357 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MONOETHANOLAMINE	2-AMINOETHANOL	5KV86114PT	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	9.5 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL		2575 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, DELAYED RELEASE / ORAL		2313 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, FILM COATED / ORAL		98 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / RESPIRATORY (INHALATION)		25 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, EXTENDED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, ORALLY DISINTEGRATING / ORAL		17 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, COATED, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, COATED / ORAL		7 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, CHEWABLE / ORAL		34 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		10 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, COATED / ORAL	1.18 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / ORAL		50 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAMUSCULAR		150 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE, EXTENDED RELEASE / ORAL		288 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	690 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii candidate 27 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
N022032-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2007-12-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022032-001	12599565	2030-01-31		Drug product	2026-05-11

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	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`e64feba35796…`

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
a958dac3-8156-4222-a379-82fb3c229a74			0022ca14-9177-4fe9-90f3-1d67592d8d6c	2014-05-22	Warnings	Exact identifier spl id: a958dac3-8156-4222-a379-82fb3c229a74 spl set id: 0022ca14-9177-4fe9-90f3-1d67592d8d6c

Reported adverse events (FAERS/openFDA)#

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