Omeprazole
- Product NDC
- 10544-295
- 11-digit product format
- 105440295
- Labeler code
- 10544
- Product ID
- 10544-295_11a46141-f467-0131-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA075876
- Marketing category
- ANDA
- Marketing start
- 2013-09-30
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 10544-295 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 10544-295 | 10544-295-90 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 10544-295 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | ||
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 10544-295 | 10544-295-90 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | 10544-295 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | ||
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 10544-295 | 10544-295-90 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 10544-295 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 10544-295 | 10544-295-90 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | 10544-295 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | ||
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10544-295 | 10544-295-90 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 10544-295 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 10544-295 | 10544-295-90 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 10544-295 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 10544-295 | 10544-295-90 | 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 |
|---|---|---|---|---|---|---|---|
| A075876-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | ||
| A075876-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | ||
| A075876-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 |
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 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A075876-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A075876-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075876-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075876-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075876-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075876-003 | AB | 1 | ea99ee380514… |