Esomeprazole Magnesium
- Product NDC
- 71335-0709
- 11-digit product format
- 713350709
- Labeler code
- 71335
- Product ID
- 71335-0709_b2fc53fb-9db7-4b7e-872c-3c6986ba1317
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078279
- Marketing category
- ANDA
- Marketing start
- 2015-12-10
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 71335-0709 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 71335-0709 | 71335-0709-1 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-0709 | 71335-0709-2 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-0709 | 71335-0709-3 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-0709 | 71335-0709-4 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-0709 | 71335-0709-5 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-0709 | 71335-0709-6 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-0709 | 71335-0709-7 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-0709 | 71335-0709-8 | D | Discontinued by firm | 2026-08-11 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0709-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0709-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0709-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0709-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0709-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0709-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0709-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0709-7 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0709-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0709-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0709-8 | 302b2466d912… | e7b80fea0513… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078279-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | |
| A078279-002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078279-001 | AB |
| A078279-002 | 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 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078279-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078279-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-09-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078279-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078279-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078279-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078279-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078279-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078279-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078279-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078279-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078279-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078279-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078279-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078279-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078279-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078279-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078279-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078279-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078279-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078279-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078279-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078279-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078279-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078279-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078279-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078279-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078279-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078279-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078279-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078279-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078279-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078279-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078279-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078279-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078279-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078279-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078279-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078279-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078279-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078279-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078279-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078279-002 | AB | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc. | a9d05a38-08db-4710-b6f3-20c92ce885d5 | 2026-04-13 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | AvPAK | 4db9f4b8-b6df-f6e9-e063-6294a90a9f60 | 2026-03-31 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | NuCare Pharmaceuticals, Inc. | 463c9b3b-dd6b-7ee7-e063-6394a90afb43 | 2025-12-18 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | PD-Rx Pharmaceuticals, Inc. | fdea1f5f-b717-4d49-8d70-0b373c959bf0 | 2025-10-14 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | NuCare Pharmaceuticals,Inc. | 2879c79f-bf2a-0bc9-e063-6394a90a98ae | 2025-04-28 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Major Pharmaceuticals | ba65c73d-fc7d-491e-aaaa-cf45a7783395 | 2025-01-07 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Medsource Pharmaceuticals | 1278cf6f-cc7a-462b-e063-6394a90a34e5 | 2024-02-28 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | A-S Medication Solutions | 71956762-d2f7-4763-9afe-1ca8f32a3cbb | 2023-12-27 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | A-S Medication Solutions | 99fceec8-59a2-485f-a7f3-7c5afd98401d | 2023-12-27 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Dr. Reddy's Laboratories Inc | 15023261-51c8-2388-3439-48dace49ec02 | 2023-07-25 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | NorthStar Rx LLC | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 2023-07-15 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Proficient Rx LP | e5540d90-0b6e-4519-9272-c6e96730967b | 2023-02-01 | Warnings, Adverse reactions | 078279 ANDA078279 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Proficient Rx LP | 9224142a-6e14-4ca3-9e72-506ff9fbd0e1 | 2022-07-01 | Warnings, Adverse reactions | 078279 ANDA078279 |