up and up omeprazole
- Product NDC
- 11673-212
- Requested package NDC
- 11673-212-74
- 11-digit product format
- 116730212
- Labeler code
- 11673
- Product ID
- 11673-212_1713a351-8a7a-405c-b37d-e01c2de0c246
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Target Corporation
- Application
- NDA209400
- Marketing category
- NDA
- Marketing start
- 2018-05-09
- 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 | 11673-212 | 11673-212-74 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 11673-212 | 11673-212-74 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209400-001 | OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | |
| N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 |
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 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD | 2017-07-05 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209400-001 | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | RLD, RS | 2017-07-05 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209400-001 | 10835488 | 2036-12-08 | Drug product | 2020-11-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209400-001 | 10076494 | 2036-12-08 | Drug product | 2018-09-18 | 87673890dc5c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- up and up 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 |
|---|---|
| 2003656 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56 | Available on FDA.report |
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 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-212-55 | up and up omeprazole | 14 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 14 | 5 | |
| 11673-212-55 | up and up omeprazole | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 3 | 5 | |
| 11673-212-74 | up and up omeprazole | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING, D | 1 | 5 | |
| 11673-212-74 | up and up omeprazole | 14 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 14 | 5 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2003656 | omeprazole 20 MG Delayed Release Disintegrating Oral Tablet | PSN | 8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56 | 5 |
| 2003656 | omeprazole 20 MG Disintegrating Oral Tablet | SCD | 8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56 | 5 |
| 2003656 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral Tablet | SY | 8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11673-212-74 | 11673021274 | 14 BLISTER PACK in 1 CARTON (11673-212-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 14 blister pack | 2018-05-09 | 0000-00-00 | No | No | Current |