Omeprazole Delayed Release Tablets, 20 mg

Manufacturer
Dexcel Ltd.
Effective date
2010-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:53:08

Label at a glance#

ProductOmeprazole Delayed Release
Active ingredientOmeprazole
Label structure13 sections

Label contents#

Full prescribing information#

Omeprazole Delayed Release Tablets, 20 mg Drug Facts

OTC - ACTIVE INGREDIENT SECTION


Active ingredient (in each tablet)
Omeprazole delayed-release tablet, 20 mg

OTC - PURPOSE SECTION

Purpose
Acid reducer

INDICATIONS & USAGE SECTION


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 SECTION


Warning
Allergy alert:  Do not use if you are allergic to omeprazole

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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 or 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking

  • clopidogrel bisulfate (anti-blood clotting medicine)
  • warfarin (blood-thinning medicine)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus (immune system medicine)
  • atazanavir (medicine for HIV infection)

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.
(1-800-2221222)

SPL UNCLASSIFIED SECTION


Directions
  • 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 chew or crush the tablets
  • do not crush tablets in food
  • do not use for more than 14 days unless directed by your doctor
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

SPL UNCLASSIFIED SECTION


Other information
  • read the directions, warnings, and package insert before use
  • keep the carton and package insert.  They contain important information.
  • store at 20-25°C (68-77°F)
  • keep product out of high heat and humidity
  • protect product from moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients 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

OTC - QUESTIONS SECTION


Questions or comments?
1-800-719-9260

Inner Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Treats Frequent Heartburn!
Occurring 2 or More Days a Week

Omeprazole
delayed release tablets 20 mg
acid reducer

14 TABLETS
One 14-day course of treatment

Inner Carton LabelInner Carton Label

Blister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Omeprazole DR Tablets
20 mg

Acid reducer
Push tablet through foil.
Dexcel Ltd.
1 Dexcel St.  Or Akiva
30600, Israel

Do not chew or crush tablets

Do not crush tablets in food


Blister Label
Blister Label

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NOT FOR RESALE

Treats Frequent Heartburn!
Occurring 2 or More Days a Week

Omeprazole Delayed
Release Tablets 20 mg

Acid Reducer

14 Tablets
One 14-day course of treatment

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:
Dexcel® Ltd.
1 Dexcel St., Or Akiva
30600, Israel

Made in Israel

Bottle Label Part 1
Bottle Label Part 1
Bottle Label Part 2
Bottle Label Part 2
Bottle Label Part 3
Bottle Label Part 3



Patient Package Insert

SPL PATIENT PACKAGE INSERT SECTION


Omeprazole Delayed Release Tablets 20 mg

Acid Reducer

Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg.  Save this to read, as you need.

How Omeperazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn

Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid.  Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days.

What to Expect When Using Omeprazole Delayed Release Tablets 20 mg

Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.  Make sure you take the entire 14 days of dosing to treat your frequent heartburn.

Safety Record

For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely.

Who Should Take Omeprazole Delayed Release Tablets 20 mg

This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.
  • Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn.
How to Take Omeprazole Delayed Release Tablets 20 mg

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 chew or crush the tablets.
  • Do not crush tablets in food.
  • Do not use for more than 14 days unless directed by your doctor.
It is important not to chew or crush these tablets, or crush the tablets in food.  This decreases how well Omeprazole Delayed Release Tablets 20 mg work.

When to Take Omeprazole Delayed Release Tablets 20 mg Again

You may repeat a 14-day course of therapy every 4 months.


When to Talk to Your Doctor

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

Warnings and When to Ask Your Doctor

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
  • clopidogrel bisulfate (anti-blood clotting medicine)
  • warfarin (blood-thinning medicine)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus (immune system medicine)
  • atazanavir (medicine 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
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)

Tips for Managing Heartburn
  • Do not lie flat or bend over soon after eating.
  • Do not eat late at night or just before bedtime.
  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables.
  • Eat slowly and do not eat big meals.
  • If you are overweight, lose weight.
  • If you smoke, quit smoking.
  • Raise the head of your bed.
  • Wear loose-fitting clothing around your stomach.
How are Omeprazole Delayed Release Tablets 20 mg Sold

Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes.  These sizes contain one, two and three 14-day courses of treatment, respectively.  Do not use for more than 14 days in a row unless directed by your doctor.  For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg

Call 1-800-719-9260

Made in Israel

Manufactured by:
DEXCEL® LTD.
Southern Industrial Zone
Or Akiva 30600, Israel


Bulk 7-Count Blister Pack Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


70 Tablets

OMEPRAZOLE DR TABLETS 20 MG OTC
Acid reducer

FOR REPACKAGING ONLY

Manufactured by:  DEXCEL® LTD.
Southern Industrial Zone, Or Akiva 30600, Israel

  • Store at 15° - 25°C (59° - 77°F)
  • Keep product out of high heat and humidity
  • Protect product from moisture
Bulk 7-Count Blister Carton Label
Bulk 7-Count Blister Carton Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX91
OmeprazoleACTIVE MOIETYKG60484QX91
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZ1
EthanolamineINACTIVE INGREDIENT5KV86114PT1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6751
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRT1
HypromelloseINACTIVE INGREDIENT3NXW29V3WO1
Hypromellose Acetate Succinate 12070923 (3 MM2/S)INACTIVE INGREDIENT36BGF0E8891
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5X1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141J1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A21
Sodium StearateINACTIVE INGREDIENTQU7E2XA9TG1
Sodium Stearyl FumarateINACTIVE INGREDIENT7CV7WJK4UI1
TalcINACTIVE INGREDIENT7SEV7J4R1U1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UM1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64861-30364861-303-01, 64861-303-02, 64861-303-03

Ingredients#

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

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

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HypromelloseHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
Sodium StearateSODIUM STEARATEQU7E2XA9TGTABLET, ORALLY DISINTEGRATING / ORAL0.85 mgExact identifier — unii candidate
3 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii candidate
27 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
TalcTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
Sodium Stearyl FumarateSODIUM STEARYL FUMARATE7CV7WJK4UIGRANULE / ORAL77 mgExact identifier — unii candidate
17 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY47.5 mgExact identifier — unii candidate
38 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XGRANULE, FOR SUSPENSION / ORALNAExact identifier — unii candidate
38 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / BUCCAL43 mgExact identifier — unii candidate
38 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii candidate
42 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED, EXTENDED RELEASE / ORAL140 mgExact identifier — unii candidate
11 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JINSERT / VAGINAL15 mgExact identifier — unii candidate
42 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium Stearyl FumarateSODIUM STEARYL FUMARATE7CV7WJK4UIPELLET / ORAL43 mgExact identifier — unii candidate
17 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii candidate
27 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, FILM COATED / ORAL968 mgExact identifier — unii candidate
38 equally ranked IID candidates
Triethyl CitrateTRIETHYL CITRATE8Z96QXD6UMCAPSULE, DELAYED RELEASE / ORAL70 mgExact identifier — unii candidate
19 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JGEL / VAGINAL0.2 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
Hypromellose Acetate Succinate 12070923 (3 MM2/S)HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MPA.S)36BGF0E889CAPSULE, DELAYED RELEASE / ORAL104 mgExact identifier — unii candidate
2 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
Triethyl CitrateTRIETHYL CITRATE8Z96QXD6UMTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
19 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR214 mgExact identifier — unii candidate
38 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XPOWDER / RESPIRATORY (INHALATION)25 mgExact identifier — unii candidate
38 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE, COATED PELLETS / ORAL265 mgExact identifier — unii candidate
38 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, EXTENDED RELEASE / ORAL2150 mgExact identifier — unii candidate
11 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii candidate
27 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii candidate
27 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii candidate
27 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET / SUBLINGUAL1.1 mgExact identifier — unii candidate
42 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, CHEWABLE / ORAL1412 mgExact identifier — unii candidate
38 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS214 mgExact identifier — unii candidate
38 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022032-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022032-001125995652030-01-31Drug product2026-05-11

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2026-08-18 06:07:402026-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043f01610625f2…
2019-09-15 20:21 UTC2019-09N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04b00525d2431f…
2019-07-19 19:46 UTC2019-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022032-001125995652030-01-31Drug product2026-05-1184e616aacf4f…
2026-08-18 06:07:402026-07N022032-001125995652030-01-31Drug product2026-05-11caaa826d4ba7…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022032-00190233912025-08-16Drug product2015-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022032-00190233912025-08-16Drug product2015-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022032-00190233912025-08-16Drug product2015-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022032-00190233912025-08-16Drug product2015-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022032-00190233912025-08-16Drug product2015-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022032-00190233912025-08-16Drug product2015-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022032-00190233912025-08-16Drug product2015-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022032-00190233912025-08-16Drug product2015-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022032-00190233912025-08-16Drug product2015-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022032-00190233912025-08-16Drug product2015-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022032-00190233912025-08-16Drug product2015-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022032-00190233912025-08-16Drug product2015-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022032-00190233912025-08-16Drug product2015-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022032-00190233912025-08-16Drug product2015-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022032-00190233912025-08-16Drug product2015-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022032-00190233912025-08-16Drug product2015-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022032-00190233912025-08-16Drug product2015-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022032-00190233912025-08-16Drug product2015-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022032-00190233912025-08-16Drug product2015-06-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022032-00190233912025-08-16Drug product2015-06-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N022032-00190233912025-08-16Drug product2015-06-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022032-00190233912025-08-16Drug product2015-06-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022032-00190233912025-08-16Drug product2015-06-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022032-00190233912025-08-16Drug product2015-06-033f01610625f2…
2019-09-15 20:21 UTC2019-09N022032-00190233912025-08-16Drug product2015-06-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N022032-00190233912025-08-16Drug product2015-06-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022032-00190233912025-08-16Drug product2015-06-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022032-00190233912025-08-16Drug product2015-06-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022032-00190233912025-08-16Drug product2015-06-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022032-00190233912025-08-16Drug product2015-06-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022032-00190233912025-08-16Drug product2015-06-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022032-00190233912025-08-16Drug product2015-06-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022032-00190233912025-08-16Drug product2015-06-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N022032-00190233912025-08-16Drug product2015-06-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N022032-00190233912025-08-16Drug product2015-06-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022032-00190233912025-08-16Drug product2015-06-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022032-00190233912025-08-16Drug product2015-06-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022032-00190233912025-08-16Drug product2015-06-03e64feba35796…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5b97f373-690c-4a84-b3f6-24353f50f77180e8ed4e-25af-4297-bd15-901e6120323d2010-04-27WarningsExact identifier
spl id: 5b97f373-690c-4a84-b3f6-24353f50f771
spl set id: 80e8ed4e-25af-4297-bd15-901e6120323d

Reported adverse events (FAERS/openFDA)#

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