omeprazole
- Product NDC
- 42507-414
- 11-digit product format
- 425070414
- Labeler code
- 42507
- Product ID
- 42507-414_c7e11072-2333-4846-a37b-2b2c3a59a6d0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- NDA022032
- Marketing category
- NDA
- Marketing start
- 2026-01-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
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… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- omeprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| KG60484QX9 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 402014 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cf9919e6-a839-4bad-a007-80d5bf6f81db | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 424daadb-95de-8ece-97f5-235e3f7f0001 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42507-414-00 | omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 2 | |
| 42507-414-01 | omeprazole | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 2 | |
| 42507-414-42 | omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | PSN | cf9919e6-a839-4bad-a007-80d5bf6f81db | 2 |
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | SCD | cf9919e6-a839-4bad-a007-80d5bf6f81db | 2 |
| 402014 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | cf9919e6-a839-4bad-a007-80d5bf6f81db | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-414-00 | 42507041400 | 14 in 1 BOTTLE | Historical | ||||
| 42507-414-01 | 42507041401 | 1 BOTTLE in 1 CARTON (42507-414-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) | 1 bottle | 2026-01-28 | No | No | Current |
| 42507-414-42 | 42507041442 | 3 BOTTLE in 1 CARTON (42507-414-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) | 3 bottle | 2026-01-28 | No | No | Current |