Esomeprazole Magnesium
- Product NDC
- 56062-898
- 11-digit product format
- 560620898
- Labeler code
- 56062
- Product ID
- 56062-898_dd61324d-e918-43f2-8c65-ddbdf7102fee
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Publix Super Markets Inc
- Application
- ANDA207193
- Marketing category
- ANDA
- Marketing start
- 2017-09-29
- Substance
- ESOMEPRAZOLE
- 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
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 |
|---|---|---|---|---|---|
| 2025-08-27 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 | 56062-898-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 56062-898-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 56062-898-03 | 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 | 56062-898-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 56062-898-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 56062-898-03 | 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 | 56062-898-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 56062-898-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 56062-898-03 | 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 | 56062-898-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 56062-898-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 56062-898-03 | 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 | 56062-898-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 56062-898-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 56062-898-03 | 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 | 56062-898-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 56062-898-02 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 56062-898-03 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 56062-898-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 56062-898-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 56062-898-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 56062-898-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 56062-898-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 56062-898-03 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 56062-898-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 56062-898-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 56062-898-03 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 56062-898-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 56062-898-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 56062-898-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 56062-898-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 56062-898-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 56062-898-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207193-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 |
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 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esomeprazole Magnesium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESOMEPRAZOLE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N3PA6559FT | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 606726 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60554fd6-96d5-4e73-b676-332116caa800 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 8 | 20171212 |
| 094c6751-235c-4d12-acee-2baf94f676f4 | Product name | 1 | 20151116 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 56062-898-01 | Esomeprazole Magnesium | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | 5 | |
| 56062-898-01 | Esomeprazole Magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 5 | |
| 56062-898-02 | Esomeprazole Magnesium | 2 in 1 CARTON | CAPSULE, DELAYED RELEASE | 2 | 5 | |
| 56062-898-02 | Esomeprazole Magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 5 | |
| 56062-898-03 | Esomeprazole Magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 5 | |
| 56062-898-03 | Esomeprazole Magnesium | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | 5 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 60554fd6-96d5-4e73-b676-332116caa800 | 5 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 60554fd6-96d5-4e73-b676-332116caa800 | 5 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 60554fd6-96d5-4e73-b676-332116caa800 | 5 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | 60554fd6-96d5-4e73-b676-332116caa800 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 56062-898-01 | 56062089801 | 1 BOTTLE in 1 CARTON (56062-898-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2017-09-29 | No | No | Current |
| 56062-898-02 | 56062089802 | 2 BOTTLE in 1 CARTON (56062-898-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2017-09-29 | No | No | Current |
| 56062-898-03 | 56062089803 | 3 BOTTLE in 1 CARTON (56062-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2017-09-29 | No | No | Current |