omeprazole
- Product NDC
- 11822-0915
- Requested package NDC
- 11822-0915-6
- 11-digit product format
- 118220915
- Labeler code
- 11822
- Product ID
- 11822-0915_d6ea9fab-5820-401b-9ed1-a36b95afc717
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- NDA022032
- Marketing category
- NDA
- Marketing start
- 2008-02-25
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 11822-0915 | 11822-0915-6 | D | Discontinued by firm | 2026-08-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022032-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2007-12-04 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022032-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2007-12-04 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022032-001 | 9023391 | 2025-08-16 | Drug product | 2015-06-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022032-001 | 12599565 | 2030-01-31 | Drug product | 2026-05-11 | a50c72e98297… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-0915-1 | omeprazole | 2 in 1 CARTON | TABLET, DELAYED RELEASE | 2 | 7 | |
| 11822-0915-1 | omeprazole | 14 in 1 CARTON | TABLET, DELAYED RELEASE | 14 | 7 | |
| 11822-0915-2 | omeprazole | 14 in 1 CARTON | TABLET, DELAYED RELEASE | 14 | 7 | |
| 11822-0915-2 | omeprazole | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 7 | |
| 11822-0915-3 | omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | 7 | |
| 11822-0915-3 | omeprazole | 14 in 1 CARTON | TABLET, DELAYED RELEASE | 14 | 7 | |
| 11822-0915-4 | omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 7 | |
| 11822-0915-4 | omeprazole | 2 in 1 CARTON | TABLET, DELAYED RELEASE | 2 | 7 | |
| 11822-0915-5 | omeprazole | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 7 | |
| 11822-0915-5 | omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 7 | |
| 11822-0915-6 | omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 7 | |
| 11822-0915-6 | omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-0915 | OMEPRAZOLE TABLET, DELAYED RELEASE [RITE AID CORPORATION] | 7 | Current NDC, Legacy NDC, 12 package rows | 20231103_4bb2866d-15b5-42a2-8cda-c7d41259a4af.zip |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | PSN | 4bb2866d-15b5-42a2-8cda-c7d41259a4af | 7 |
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | SCD | 4bb2866d-15b5-42a2-8cda-c7d41259a4af | 7 |
| 402014 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | 4bb2866d-15b5-42a2-8cda-c7d41259a4af | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-0915-6 | 11822091506 | 3 BOTTLE in 1 CARTON (11822-0915-6) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2011-12-27 | 0000-00-00 | No | No | Current |