Omeprazole
- Product NDC
- 43598-841
- 11-digit product format
- 435980841
- Labeler code
- 43598
- Product ID
- 43598-841_bf20de45-af46-d037-efd5-6efe069d0569
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA207740
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207740-001 | OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A207740-001 | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE / ORAL | 2018-11-05 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2026-12-31
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 |
|---|---|
| b377cb0b-14b2-04bb-f276-fd69a257f9ca | 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 |
|---|---|---|---|---|---|---|
| 43598-841-42 | Omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | 4 | |
| 43598-841-42 | Omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 4 | |
| 43598-841-52 | Omeprazole | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 4 | |
| 43598-841-52 | Omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 4 |
DailyMed Dashboard NDC Coverage#
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 | AMERISOURCEBERGEN DRUG CORPORATION | 0521c51b-d113-7e35-f1a6-c4495a2bcfcc | 2026-04-17 | Warnings | 207740 ANDA207740 |
| Omeprazole | OMEPRAZOLE | Walmart Inc. | 5168ccd9-31b4-3a49-85b9-4f202cd99f6b | 2026-03-19 | Warnings | 207740 ANDA207740 |
| Omeprazole | OMEPRAZOLE | Chain Drug Marketing Association INC | 77d4f6c7-87ca-78bb-3310-2304a68f9f9b | 2025-01-17 | Warnings | 207740 ANDA207740 |
| Omeprazole | OMEPRAZOLE | Dr. Reddys Laboratories Inc | 4b3b389d-a151-d851-cb05-64eb49979e5e | 2024-12-19 | Warnings | 207740 ANDA207740 |
| Omeprazole | OMEPRAZOLE | Walgreens Company | 5e2994fc-8f44-f6e4-71fe-44a215aa93a9 | 2024-11-10 | Warnings | 207740 ANDA207740 |
| Omeprazole | OMEPRAZOLE | Dr. Reddys Laboratories Inc | b377cb0b-14b2-04bb-f276-fd69a257f9ca | 2024-11-10 | Warnings | 207740 ANDA207740 43598-841 |
| Omeprazole | OMEPRAZOLE | BluePoint Laboratories | a86d52a5-15e2-012d-e053-2a95a90ac912 | 2023-09-13 | Warnings | 207740 ANDA207740 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | PSN | b377cb0b-14b2-04bb-f276-fd69a257f9ca | 4 |
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | SCD | b377cb0b-14b2-04bb-f276-fd69a257f9ca | 4 |
| 402014 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | b377cb0b-14b2-04bb-f276-fd69a257f9ca | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43598-841-42 | 43598084142 | 3 BOTTLE in 1 CARTON (43598-841-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |
| 43598-841-52 | 43598084152 | 1 BOTTLE in 1 CARTON (43598-841-52) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |