Indications and uses
treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
omeprazole
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2019-04-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:28:13
Label at a glance#
Productomeprazole
Active ingredientOMEPRAZOLE
Label structure9 sections
Dosage and administration
for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 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 di...
Storage and handling
read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) and protect from moisture
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Omeprazole 20 mg
Purpose
Acid reducer
Uses
- treats frequent heartburn (occurs 2 or more days a week)
- not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Warnings
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
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have:
- had heartburn over 3 months. This may be a sign of a more serious condition.
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
Ask a doctor or pharmacist before use if you are taking:
- warfarin, clopidogrel or cilostazol (blood-thinning medicines)
- prescription antifungal or anti-yeast medicines
- diazepam (anxiety medicine)
- digoxin (heart medicine)
- tacrolimus or mycophenolate mofetil (immune system medicines)
- prescription antiretrovirals (medicines for HIV infection)
- methotrexate (arthritis medicine)
Stop use and ask a doctor if:
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- you need to take more than 1 course of treatment every 4 months
- you get diarrhea
- you develop a rash or joint pain
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- for adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
- 14-Day Course of Treatment
- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew or crush tablets
- Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
Other information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20-25°C (68-77°F) and protect from moisture
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
Questions or comments?
1-800-719-9260
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: omeprazole
GENERIC: Omeprazole
DOSAGE: TABLET, DELAYED RELEASE
ADMINSTRATION: ORAL
NDC: 70518-0537-0
COLOR: brown
SHAPE: OVAL
SCORE: No score
SIZE: 17 mm
IMPRINT: 20
PACKAGING: 100 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- OMEPRAZOLE 20mg in 1
INACTIVE INGREDIENT(S):
- CARNAUBA WAX
- SODIUM STEARATE
- SODIUM STEARYL FUMARATE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- PROPYLENE GLYCOL
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- HYPROMELLOSES
- LACTOSE MONOHYDRATE
- MONOETHANOLAMINE
- TRIETHYL CITRATE
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-0537-0 | 2021-02-18 | C162847 | 48780-1 | ba0f9c33-1063-a910-e053-dadaa90a0b85 | Perrigo Omeprazole Drug Facts |
| 70518-0537-0 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1063-a910-e053-dadaa90a0b85 | Perrigo Omeprazole Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-888-30 | EA - Each | 45802-888 | ec086e1a-0cbd-4315-b77f-c4035df8fe86 | 1 | 2012-07-24 |
| 45802-888-55 | EA - Each | 45802-888 | 942744c2-554a-474b-a4d6-8d5c757780ae | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- omeprazole
- CARNAUBA WAX
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- HYPROMELLOSES
- LACTOSE MONOHYDRATE
- MONOETHANOLAMINE
- PROPYLENE GLYCOL
- SODIUM LAURYL SULFATE
- SODIUM STEARATE
- SODIUM STEARYL FUMARATE
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-0537 | 70518-0537-0 |
| 45802-888 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MONOETHANOLAMINE | 5KV86114PT | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM STEARATE | QU7E2XA9TG | IACT |
| SODIUM STEARYL FUMARATE | 7CV7WJK4UI | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIETHYL CITRATE | 8Z96QXD6UM | IACT |
| OMEPRAZOLE | KG60484QX9 | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| omeprazole | OMEPRAZOLE | Padagis Israel Pharmaceuticals Ltd | cb47354c-297b-4dc2-85af-242acc967b56 | 2025-02-06 | Warnings | 45802-888 |
| a2aca353-75ee-fb7c-e053-2a95a90aaee0 | 1bd258fe-9c2f-4b0f-99dc-84474c298cad | 2021-01-09 | Warnings | 1bd258fe-9c2f-4b0f-99dc-84474c298cad |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.