Omeprazole
- Product NDC
- 55111-158
- Requested package NDC
- 55111-158-86
- 11-digit product format
- 551110158
- Labeler code
- 55111
- Product ID
- 55111-158_0dc50704-e0d5-1fcc-b0b5-6e5556db65e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- 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 |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | 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 21:27 UTC · source 2025-12-05 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 906f6e251498… | bf70b80e44f0… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8fc7167e32ce… | e96bbc724034… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 55111-158 | 55111-158-86 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075576-001 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | |
| A075576-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A075576-003 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075576-001 | AB |
| A075576-002 | AB |
| A075576-003 | AB |
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 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075576-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075576-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075576-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075576-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075576-001 | AB | 1 | 8072bd15b7f6… |
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 | St. Mary's Medical Park Pharmacy | 1eb57c13-25ed-70bc-e063-6294a90afdac | 2026-06-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | aae3bf9f-5d05-889f-e053-2995a90a5ff2 | 2025-12-26 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | QPharma, Inc. | f5dcf0b2-4fa2-023a-e053-2995a90a183a | 2025-12-01 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Quallent Pharmaceuticals Health LLC | 665e9877-85ac-fdb6-54ac-1c47941ceab8 | 2025-11-28 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | PD-Rx Pharmaceuticals, Inc. | e235ef89-3592-4ca1-8c13-d7ce84b1001c | 2025-10-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | American Health Packaging | a17e415e-a559-4a8d-a455-699184a01523 | 2025-02-17 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | af85e324-ef9f-196c-e053-2995a90a384e | 2024-12-31 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Quality Care Products, LLC | 581d1c3d-457a-41f2-8db0-5b6219cdcb09 | 2024-12-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | f0f61a89-700d-481d-9255-6f9a9afa7025 | 2024-10-01 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | 1d4ecc1e-5180-f75e-e063-6394a90a51a6 | 2024-07-15 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | e1f20429-cfaa-420b-a65a-271be37eb799 | 2024-05-28 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Dr. Reddy's Laboratories Limited | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 2024-04-15 | Warnings, Adverse reactions | 075576 ANDA075576 55111-158 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68 | 2023-09-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | NorthStar Rx LLC | c5af5f4b-17be-7245-b281-f27c87831242 | 2023-06-20 | Warnings, Adverse reactions | 075576 ANDA075576 |
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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 72fb11b6-b08c-2f02-d82b-f60f52394903 | 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 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 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 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55111-158-01 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | 28 | |
| 55111-158-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 28 | |
| 55111-158-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 28 | |
| 55111-158-34 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 28 | |
| 55111-158-34 | Omeprazole | 12 in 1 CARTON | CAPSULE, DELAYED RELEASE | 12 | 28 | |
| 55111-158-78 | Omeprazole | 10 in 1 CARTON | CAPSULE, DELAYED RELEASE | 10 | 28 | |
| 55111-158-79 | Omeprazole | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | 28 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-158-01 | EA - Each | 55111-158 | 7c5f9552-ef97-41cc-b37f-e28b4b85ba0b | 1 | 2013-02-13 |
| 55111-158-10 | EA - Each | 55111-158 | 30f4ed6d-6bc4-430b-8fec-babf25d40957 | 1 | 2013-02-13 |
| 55111-158-30 | EA - Each | 55111-158 | f90a2d1a-3bc4-49e9-a495-d364372186ff | 1 | 2013-02-13 |
| 55111-158-34 | EA - Each | 55111-158 | b739f59a-e50a-42e4-ac56-13a620e34105 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 581d1c3d-457a-41f2-8db0-5b6219cdcb09 | 339005 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 581d1c3d-457a-41f2-8db0-5b6219cdcb09 | 339005 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 581d1c3d-457a-41f2-8db0-5b6219cdcb09 | 339005 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | e235ef89-3592-4ca1-8c13-d7ce84b1001c | 32 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | e235ef89-3592-4ca1-8c13-d7ce84b1001c | 32 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | e235ef89-3592-4ca1-8c13-d7ce84b1001c | 32 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | a17e415e-a559-4a8d-a455-699184a01523 | 15 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | a17e415e-a559-4a8d-a455-699184a01523 | 15 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | a17e415e-a559-4a8d-a455-699184a01523 | 15 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68 | 13 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68 | 13 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68 | 13 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 73f77956-e7e7-4bc2-adab-67b164942d53 | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | e1f20429-cfaa-420b-a65a-271be37eb799 | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 73f77956-e7e7-4bc2-adab-67b164942d53 | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | e1f20429-cfaa-420b-a65a-271be37eb799 | 7 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | e1f20429-cfaa-420b-a65a-271be37eb799 | 7 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 73f77956-e7e7-4bc2-adab-67b164942d53 | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | aae3bf9f-5d05-889f-e053-2995a90a5ff2 | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | aae3bf9f-5d05-889f-e053-2995a90a5ff2 | 6 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | aae3bf9f-5d05-889f-e053-2995a90a5ff2 | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 43a63143-114b-2640-e054-00144ff8d46c | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 43a63143-114b-2640-e054-00144ff8d46c | 4 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 43a63143-114b-2640-e054-00144ff8d46c | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 97f62c65-ef06-4cc6-8887-46c81266a80a | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 59914d49-61d2-1634-e053-2991aa0a1041 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 4438a8ee-dfc3-42ae-8057-f5992606891f | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 737ec163-f078-c3b3-e053-2a91aa0a245c | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 56e23999-27a2-682a-e054-00144ff8d46c | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 97f62c65-ef06-4cc6-8887-46c81266a80a | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 737ec163-f078-c3b3-e053-2a91aa0a245c | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 4438a8ee-dfc3-42ae-8057-f5992606891f | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 56e23999-27a2-682a-e054-00144ff8d46c | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 59914d49-61d2-1634-e053-2991aa0a1041 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 4438a8ee-dfc3-42ae-8057-f5992606891f | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 737ec163-f078-c3b3-e053-2a91aa0a245c | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 56e23999-27a2-682a-e054-00144ff8d46c | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 59914d49-61d2-1634-e053-2991aa0a1041 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 97f62c65-ef06-4cc6-8887-46c81266a80a | 3 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 60752a58-1d6c-4b4d-98dd-d49c76d2f443 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 8772b002-c446-4581-8a14-d7a9bca62385 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 4349207c-5253-49fb-95ef-15f5ed371442 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 60752a58-1d6c-4b4d-98dd-d49c76d2f443 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 1eb57c13-25ed-70bc-e063-6294a90afdac | 2 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 60752a58-1d6c-4b4d-98dd-d49c76d2f443 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 8772b002-c446-4581-8a14-d7a9bca62385 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 4349207c-5253-49fb-95ef-15f5ed371442 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 60752a58-1d6c-4b4d-98dd-d49c76d2f443 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 1eb57c13-25ed-70bc-e063-6294a90afdac | 2 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 60752a58-1d6c-4b4d-98dd-d49c76d2f443 | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 8772b002-c446-4581-8a14-d7a9bca62385 | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 4349207c-5253-49fb-95ef-15f5ed371442 | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 1eb57c13-25ed-70bc-e063-6294a90afdac | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 60752a58-1d6c-4b4d-98dd-d49c76d2f443 | 2 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 9a77cf66-e110-4d51-ae8a-bea6207bba75 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | c10af03b-cea2-4929-bcbb-b973bf3c5704 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | ed5e0d81-0c1a-4548-bde3-03fff123f12e | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 9a77cf66-e110-4d51-ae8a-bea6207bba75 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 1d4ecc1e-5180-f75e-e063-6394a90a51a6 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 2f381ecb-1e71-4f2f-acf0-d4918e0f3a1c | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | d8b466e0-a35e-4fba-9d43-4e6c0122e7ad | 1 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 9a77cf66-e110-4d51-ae8a-bea6207bba75 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | ed5e0d81-0c1a-4548-bde3-03fff123f12e | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 1d4ecc1e-5180-f75e-e063-6394a90a51a6 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | c10af03b-cea2-4929-bcbb-b973bf3c5704 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 9a77cf66-e110-4d51-ae8a-bea6207bba75 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 2f381ecb-1e71-4f2f-acf0-d4918e0f3a1c | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | d8b466e0-a35e-4fba-9d43-4e6c0122e7ad | 1 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 9a77cf66-e110-4d51-ae8a-bea6207bba75 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 2f381ecb-1e71-4f2f-acf0-d4918e0f3a1c | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | c10af03b-cea2-4929-bcbb-b973bf3c5704 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 9a77cf66-e110-4d51-ae8a-bea6207bba75 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Status |
|---|---|---|---|---|
| 55111-158-86 | 55111015886 | 3500 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-158-86) | 25-AUG-12 | Current |