Omeprazole
- Product NDC
- 60505-0065
- 11-digit product format
- 605050065
- Labeler code
- 60505
- Product ID
- 60505-0065_8619e520-d106-4778-e92a-09b919b55c70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- ANDA076048
- Marketing category
- ANDA
- Marketing start
- 2003-11-11
- Marketing end
- 2027-01-31
- 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
- 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 | 60505-0065 | 60505-0065-0 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 60505-0065 | 60505-0065-3 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 60505-0065 | 60505-0065-5 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 60505-0065 | 60505-0065-7 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 60505-0065 | 60505-0065-8 | D | Discontinued by firm | 2026-08-17 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-0065-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-0065-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-0065-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-0065-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-0065-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-0065-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-0065-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-0065-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-0065-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-0065-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-0065-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-0065-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-0065-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-0065-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-0065-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-0065-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-0065-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-0065-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-0065-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-0065-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-0065-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-0065-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-0065-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-0065-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-0065-7 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-0065-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-0065-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-0065-8 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-0065-7 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-0065-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-0065-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-0065-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-0065-7 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-0065-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-0065-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-0065-8 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-0065-7 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-0065-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-0065-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-0065-8 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-0065-7 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-0065-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-0065-5 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-0065-8 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-0065-7 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-0065-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-0065-5 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-0065-8 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076048-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A076048-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A076048-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076048-001 | AB |
| A076048-002 | AB |
| A076048-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-002 | 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 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076048-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076048-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076048-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
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 |
|---|---|
| b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 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 |
|---|---|---|---|---|---|---|
| 60505-0065-0 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 35 | |
| 60505-0065-1 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 35 | |
| 60505-0065-2 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | 35 | |
| 60505-0065-3 | Omeprazole | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | 35 | |
| 60505-0065-3 | Omeprazole | 7 in 1 CARTON | CAPSULE, DELAYED RELEASE | 7 | 35 | |
| 60505-0065-5 | Omeprazole | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | 35 | |
| 60505-0065-7 | Omeprazole | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | 35 | |
| 60505-0065-7 | Omeprazole | 10 in 1 CARTON | CAPSULE, DELAYED RELEASE | 10 | 35 | |
| 60505-0065-8 | Omeprazole | 5000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 5000 | 35 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-0065-0 | EA - Each | 60505-0065 | a0b93b90-aa3b-427b-9732-d7adddf30122 | 1 | 2012-07-24 |
| 60505-0065-1 | EA - Each | 60505-0065 | a3c4a345-ef94-419e-b9d2-759731316d0d | 1 | 2012-07-24 |
| 60505-0065-2 | EA - Each | 60505-0065 | 1a7475d8-47a9-41ef-86e9-3801139e81e1 | 1 | 2012-07-24 |
| 60505-0065-7 | EA - Each | 60505-0065 | 360584cc-f4ca-4b44-9ffe-370b1974494a | 1 | 2012-07-24 |
| 60505-0065-8 | EA - Each | 60505-0065 | edf88be9-edfa-48bb-977f-602d1475398a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-0065 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP] | 35 | Current NDC, Legacy NDC, 9 package rows | 20240423_b83329ac-a65e-b3af-a3fb-c5a6c740e5e7.zip |
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 | Bryant Ranch Prepack | 1249c42d-6358-48b3-8fe0-10333c7f501d | 2024-10-31 | Warnings, Adverse reactions | 076048 ANDA076048 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 44349466-73ea-4053-8ff6-5b4b7372c9cd | 2024-10-03 | Warnings, Adverse reactions | 076048 ANDA076048 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 03ac077f-3873-4087-96d0-89049161dea9 | 2024-10-01 | Warnings, Adverse reactions | 076048 ANDA076048 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 253451a6-02a9-4b27-aed7-f3dbc2e09682 | 2024-10-01 | Warnings, Adverse reactions | 076048 ANDA076048 |
| Omeprazole | OMEPRAZOLE | Apotex Corp | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 2024-04-22 | Warnings, Adverse reactions | 076048 ANDA076048 60505-0065 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | a0dc4ffa-db18-4871-9d36-51d02e3b2bd9 | 2019-03-20 | Warnings, Adverse reactions | 076048 ANDA076048 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 35 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | c6bc8fb7-2862-464a-b7c9-e409034f072a | 14 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | c6bc8fb7-2862-464a-b7c9-e409034f072a | 14 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | c6bc8fb7-2862-464a-b7c9-e409034f072a | 14 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | c6bc8fb7-2862-464a-b7c9-e409034f072a | 14 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | c6bc8fb7-2862-464a-b7c9-e409034f072a | 14 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 03ac077f-3873-4087-96d0-89049161dea9 | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 03ac077f-3873-4087-96d0-89049161dea9 | 7 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 03ac077f-3873-4087-96d0-89049161dea9 | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 03ac077f-3873-4087-96d0-89049161dea9 | 7 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 03ac077f-3873-4087-96d0-89049161dea9 | 7 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 03ac077f-3873-4087-96d0-89049161dea9 | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | ddef12fa-1585-4b0c-b148-da0c35e56515 | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 44349466-73ea-4053-8ff6-5b4b7372c9cd | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 43028d58-90a1-1bf1-e054-00144ff8d46c | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 44349466-73ea-4053-8ff6-5b4b7372c9cd | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | ddef12fa-1585-4b0c-b148-da0c35e56515 | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 44349466-73ea-4053-8ff6-5b4b7372c9cd | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 43028d58-90a1-1bf1-e054-00144ff8d46c | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 44349466-73ea-4053-8ff6-5b4b7372c9cd | 5 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 44349466-73ea-4053-8ff6-5b4b7372c9cd | 5 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | ddef12fa-1585-4b0c-b148-da0c35e56515 | 5 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 43028d58-90a1-1bf1-e054-00144ff8d46c | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 0f560bc9-9f40-0f96-e054-00144ff88e88 | 4 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 0f560bc9-9f40-0f96-e054-00144ff88e88 | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 0f560bc9-9f40-0f96-e054-00144ff88e88 | 4 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 0f560bc9-9f40-0f96-e054-00144ff88e88 | 4 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 0f560bc9-9f40-0f96-e054-00144ff88e88 | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 1aec7a73-e035-42ae-a1a3-9f4cd4e31b71 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 80cbc57e-d864-4c17-bd64-b5206ee55aab | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 83a0bb34-405b-4aea-9557-4f8b8fd811d7 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 8750bc89-340d-4abf-b0b8-b83012ab7cae | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 80cbc57e-d864-4c17-bd64-b5206ee55aab | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 83a0bb34-405b-4aea-9557-4f8b8fd811d7 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 8750bc89-340d-4abf-b0b8-b83012ab7cae | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 1aec7a73-e035-42ae-a1a3-9f4cd4e31b71 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 1aec7a73-e035-42ae-a1a3-9f4cd4e31b71 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 8750bc89-340d-4abf-b0b8-b83012ab7cae | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 83a0bb34-405b-4aea-9557-4f8b8fd811d7 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 80cbc57e-d864-4c17-bd64-b5206ee55aab | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 1249c42d-6358-48b3-8fe0-10333c7f501d | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 11a810ca-72e8-1d9b-e054-00144ff88e88 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 1249c42d-6358-48b3-8fe0-10333c7f501d | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 11a810ca-72e8-1d9b-e054-00144ff88e88 | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 1249c42d-6358-48b3-8fe0-10333c7f501d | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 11a810ca-72e8-1d9b-e054-00144ff88e88 | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 598da612-ccb1-7c5d-e053-2a91aa0ae771 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 08b0a9cc-208a-45ff-96a6-50109a325388 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 08b0a9cc-208a-45ff-96a6-50109a325388 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 598da612-ccb1-7c5d-e053-2a91aa0ae771 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 598da612-ccb1-7c5d-e053-2a91aa0ae771 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 08b0a9cc-208a-45ff-96a6-50109a325388 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60505-0065-0 | 60505006500 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-0) | 2003-11-11 | 0000-00-00 | No | No | Current | |
| 60505-0065-1 | 60505006501 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-1) | 2003-11-11 | 2027-01-31 | No | No | Current | |
| 60505-0065-2 | 60505006502 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-2) | 2003-11-11 | 2027-01-31 | No | No | Current | |
| 60505-0065-3 | 60505006503 | 7 BLISTER PACK in 1 CARTON (60505-0065-3) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 7 blister pack | 2003-11-11 | 0000-00-00 | No | No | Current |
| 60505-0065-5 | 60505006505 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-5) | 2003-11-11 | 0000-00-00 | No | No | Current | |
| 60505-0065-7 | 60505006507 | 10 BLISTER PACK in 1 CARTON (60505-0065-7) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 10 blister pack | 2003-11-11 | 0000-00-00 | No | No | Current |
| 60505-0065-8 | 60505006508 | 5000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-8) | 2003-11-11 | 0000-00-00 | No | No | Current |