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#
Contacts and useful links#
Label contents#
Full prescribing information#
Omeprazole Delayed Release Tablets, 20 mg Drug Facts
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
- 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
- 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
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
Blister Label
Bottle Label
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



Patient Package Insert
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.
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.
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
- 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)
- 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
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.
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64861-303-01 | 2020-02-12 | C162847 | 48780-1 | 9d75b9d0-d021-f424-e053-dadaa90a57ce | Omeprazole Delayed Release Tablets, 20 mg |
| 64861-303-02 | 2020-02-12 | C162847 | 48780-1 | 9d75b9d0-d021-f424-e053-dadaa90a57ce | Omeprazole Delayed Release Tablets, 20 mg |
| 64861-303-03 | 2020-02-12 | C162847 | 48780-1 | 9d75b9d0-d021-f424-e053-dadaa90a57ce | Omeprazole Delayed Release Tablets, 20 mg |
| 64861-303-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d021-f424-e053-dadaa90a57ce | Omeprazole Delayed Release Tablets, 20 mg |
| 64861-303-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d021-f424-e053-dadaa90a57ce | Omeprazole Delayed Release Tablets, 20 mg |
| 64861-303-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d021-f424-e053-dadaa90a57ce | Omeprazole Delayed Release Tablets, 20 mg |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Omeprazole | ACTIVE INGREDIENT | KG60484QX9 | 1 | |
| Omeprazole | ACTIVE MOIETY | KG60484QX9 | 1 | |
| Carnauba Wax | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| Ethanolamine | INACTIVE INGREDIENT | 5KV86114PT | 1 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| Hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Hypromellose Acetate Succinate 12070923 (3 MM2/S) | INACTIVE INGREDIENT | 36BGF0E889 | 1 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | 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.
- Omeprazole Delayed Release
- Omeprazole
- Carnauba Wax
- Ferric Oxide Red
- Ferric Oxide Yellow
- Hypromellose
- Hypromellose Acetate Succinate 12070923 (3 MM2/S)
- Lactose Monohydrate
- Ethanolamine
- 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 |
|---|---|
| 64861-303 | 64861-303-01, 64861-303-02, 64861-303-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| Sodium Stearate | SODIUM STEARATE | QU7E2XA9TG | TABLET, ORALLY DISINTEGRATING / ORAL | 0.85 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| Talc | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| Sodium Stearyl Fumarate | SODIUM STEARYL FUMARATE | 7CV7WJK4UI | GRANULE / ORAL | 77 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | SPONGE / TOPICAL | 5 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| Sodium Stearyl Fumarate | SODIUM STEARYL FUMARATE | 7CV7WJK4UI | PELLET / ORAL | 43 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / RESPIRATORY (INHALATION) | NA | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| Triethyl Citrate | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, DELAYED RELEASE / ORAL | 70 mg | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | GEL / VAGINAL | 0.2 %w/w | ||
| Talc | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| Hypromellose Acetate Succinate 12070923 (3 MM2/S) | HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MPA.S) | 36BGF0E889 | CAPSULE, DELAYED RELEASE / ORAL | 104 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| Triethyl Citrate | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 100 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 214 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER / RESPIRATORY (INHALATION) | 25 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED PELLETS / ORAL | 265 mg | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / SUBLINGUAL | 1.1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 214 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | 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#
| Captured | Edition | Application-product | Patent | Expiration | Use code | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5b97f373-690c-4a84-b3f6-24353f50f771 | 80e8ed4e-25af-4297-bd15-901e6120323d | 2010-04-27 | Warnings | 5b97f373-690c-4a84-b3f6-24353f50f771 80e8ed4e-25af-4297-bd15-901e6120323d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


