NEXIUM
- Product NDC
- 0186-5020
- 11-digit product format
- 001865020
- Labeler code
- 0186
- Product ID
- 0186-5020_26f66e74-b652-4b1d-bfff-62a3cc87d590
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA021153
- Marketing category
- NDA
- Marketing start
- 2001-03-19
- Substance
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
- 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
- 2027-12-31
- 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 |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0186-5020 | 0186-5020-82 | D | Discontinued by firm | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021153-001 | NEXIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 |
| N021153-002 | NEXIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021153-001 | AB |
| N021153-002 | 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 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021153-001 | NEXIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2001-02-20 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021153-002 | NEXIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2001-02-20 | 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 | N021153-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021153-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021153-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021153-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021153-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021153-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021153-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021153-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021153-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021153-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021153-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021153-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021153-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021153-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021153-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021153-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021153-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021153-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021153-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021153-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021153-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021153-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021153-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021153-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021153-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021153-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021153-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021153-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021153-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021153-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021153-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021153-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021153-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021153-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021153-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021153-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021153-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021153-002 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | 6147103*PED | 2019-04-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | 6166213*PED | 2019-04-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | 6191148*PED | 2019-04-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | 6428810 | 2019-11-03 | U-729 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | 6428810 | 2019-11-03 | U-770 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | 6428810 | 2019-11-03 | U-469 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-001 | 6428810*PED | 2020-05-03 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | 6147103*PED | 2019-04-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | 6166213*PED | 2019-04-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | 6191148*PED | 2019-04-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | 6428810 | 2019-11-03 | U-770 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | 6428810 | 2019-11-03 | U-729 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | 6428810 | 2019-11-03 | U-469 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021153-002 | 6428810*PED | 2020-05-03 | Pediatric extension | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021153-001 | 6428810*PED | 2020-05-03 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021153-002 | 6428810*PED | 2020-05-03 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021153-001 | 6428810*PED | 2020-05-03 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021153-002 | 6428810*PED | 2020-05-03 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-001 | 6147103*PED | 2019-04-09 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-001 | 6166213*PED | 2019-04-09 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-001 | 6191148*PED | 2019-04-09 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-001 | 6428810 | 2019-11-03 | U-729 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021153-001 | 6428810 | 2019-11-03 | U-770 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021153-001 | 6428810 | 2019-11-03 | U-469 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021153-001 | 6428810*PED | 2020-05-03 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-002 | 6147103*PED | 2019-04-09 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-002 | 6166213*PED | 2019-04-09 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-002 | 6191148*PED | 2019-04-09 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021153-002 | 6428810 | 2019-11-03 | U-770 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021153-002 | 6428810 | 2019-11-03 | U-729 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021153-002 | 6428810 | 2019-11-03 | U-469 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021153-002 | 6428810*PED | 2020-05-03 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021153-001 | 6147103*PED | 2019-04-09 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021153-001 | 6166213*PED | 2019-04-09 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021153-001 | 6191148*PED | 2019-04-09 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021153-001 | 6428810 | 2019-11-03 | U-729 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021153-001 | 6428810 | 2019-11-03 | U-770 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021153-001 | 6428810 | 2019-11-03 | U-469 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021153-001 | 6428810*PED | 2020-05-03 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021153-002 | 6147103*PED | 2019-04-09 | Pediatric extension | b00525d2431f… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NEXIUM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R6DXU4WAY9 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 606726 | Internal RxNorm lookup |
| 606728 | Internal RxNorm lookup |
| 606730 | Internal RxNorm lookup |
| 606731 | Internal RxNorm lookup |
| 692576 | Internal RxNorm lookup |
| 692578 | Internal RxNorm lookup |
| 861568 | Internal RxNorm lookup |
| 861570 | Internal RxNorm lookup |
| 861576 | Internal RxNorm lookup |
| 861583 | Internal RxNorm lookup |
| 1297658 | Internal RxNorm lookup |
| 1297660 | Internal RxNorm lookup |
| 1297761 | Internal RxNorm lookup |
| 1297763 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f4853677-1622-4037-688b-fdf533a11d96 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 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 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0186-5020-31 | NEXIUM | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 74 | |
| 0186-5020-54 | NEXIUM | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 74 | |
| 0186-5020-82 | NEXIUM | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 74 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0186-5020-31 | EA - Each | 0186-5020 | c1defebd-54f5-4b2e-ab04-87afc6f0f687 | 1 | 2012-07-24 |
| 0186-5020-54 | EA - Each | 0186-5020 | 7a65183b-c0ba-4ca1-a849-2907953be0d7 | 1 | 2012-07-24 |
| 0186-5020-82 | EA - Each | 0186-5020 | 549ec7d8-e4b1-4846-b4d5-99f67b8f4e70 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0186-5020 | NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 72 | Current NDC, Legacy NDC, 3 package rows | 20240628_f4853677-1622-4037-688b-fdf533a11d96.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 |
|---|---|---|---|---|---|---|
| NEXIUM | ESOMEPRAZOLE MAGNESIUM | AstraZeneca Pharmaceuticals LP | f4853677-1622-4037-688b-fdf533a11d96 | 2025-12-19 | Warnings, Adverse reactions | 021153 NDA021153 0186-5020 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861568 | esomeprazole 10 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297658 | esomeprazole 2.5 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692576 | esomeprazole 20 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692578 | esomeprazole 40 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297761 | esomeprazole 5 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861570 | NexIUM 10 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297660 | NexIUM 2.5 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606728 | NexIUM 20 MG Delayed Release Oral Capsule | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861576 | NexIUM 20 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606731 | NexIUM 40 MG Delayed Release Oral Capsule | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861583 | NexIUM 40 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297763 | NexIUM 5 MG Granules for Delayed Release Oral Suspension | PSN | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861570 | esomeprazole 10 MG Granules for Oral Suspension [Nexium] | SBD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297660 | esomeprazole 2.5 MG Granules for Oral Suspension [Nexium] | SBD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606728 | esomeprazole 20 MG Delayed Release Oral Capsule [Nexium] | SBD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861576 | esomeprazole 20 MG Granules for Oral Suspension [Nexium] | SBD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606731 | esomeprazole 40 MG Delayed Release Oral Capsule [Nexium] | SBD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861583 | esomeprazole 40 MG Granules for Oral Suspension [Nexium] | SBD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297763 | esomeprazole 5 MG Granules for Oral Suspension [Nexium] | SBD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861568 | esomeprazole 10 MG Granules for Oral Suspension | SCD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297658 | esomeprazole 2.5 MG Granules for Oral Suspension | SCD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692576 | esomeprazole 20 MG Granules for Oral Suspension | SCD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692578 | esomeprazole 40 MG Granules for Oral Suspension | SCD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297761 | esomeprazole 5 MG Granules for Oral Suspension | SCD | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297658 | esomeprazole (as esomeprazole magnesium) 2.5 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692576 | esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861568 | esomeprazole 10 MG (equivalent to esomeprazole magnesium 11.1 MG) Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861568 | esomeprazole 10 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692576 | esomeprazole 20 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692578 | esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 692578 | esomeprazole 40 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297761 | esomeprazole 5 MG (equivalent to esomeprazole magnesium 5.6 MG) Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861570 | Nexium 10 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297660 | Nexium 2.5 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606728 | Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606728 | Nexium 20 MG Delayed Release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861576 | Nexium 20 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606728 | Nexium 24 HR 20 MG Delayed release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606731 | Nexium 40 MG (as esomeprazole magnesium trihydrate 44.5 MG) Delayed Release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606731 | Nexium 40 MG Delayed Release Oral Capsule | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 861583 | Nexium 40 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 1297763 | Nexium 5 MG Granules for Delayed Release Oral Suspension | SY | f4853677-1622-4037-688b-fdf533a11d96 | 74 |
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606728 | NexIUM 20 MG Delayed Release Oral Capsule | PSN | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606731 | NexIUM 40 MG Delayed Release Oral Capsule | PSN | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606728 | esomeprazole 20 MG Delayed Release Oral Capsule [Nexium] | SBD | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606731 | esomeprazole 40 MG Delayed Release Oral Capsule [Nexium] | SBD | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606728 | Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606728 | Nexium 20 MG Delayed Release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606728 | Nexium 24 HR 20 MG Delayed release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606731 | Nexium 40 MG (as esomeprazole magnesium trihydrate 44.5 MG) Delayed Release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606731 | Nexium 40 MG Delayed Release Oral Capsule | SY | a373596c-9fb3-426e-bf92-54cdd6dfc3ec | 2 |
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 6f650345-0bca-4fe9-96eb-4d7ac80928ec | 1 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606728 | NexIUM 20 MG Delayed Release Oral Capsule | PSN | 6f650345-0bca-4fe9-96eb-4d7ac80928ec | 1 |
| 606728 | NexIUM 20 MG Delayed Release Oral Capsule | PSN | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606731 | NexIUM 40 MG Delayed Release Oral Capsule | PSN | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606728 | esomeprazole 20 MG Delayed Release Oral Capsule [Nexium] | SBD | 6f650345-0bca-4fe9-96eb-4d7ac80928ec | 1 |
| 606728 | esomeprazole 20 MG Delayed Release Oral Capsule [Nexium] | SBD | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606731 | esomeprazole 40 MG Delayed Release Oral Capsule [Nexium] | SBD | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 6f650345-0bca-4fe9-96eb-4d7ac80928ec | 1 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 6f650345-0bca-4fe9-96eb-4d7ac80928ec | 1 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | ea79f802-e9ac-480b-91e6-1e3900b11803 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0186-5020-31 | 00186502031 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31) | 2001-03-19 | 0000-00-00 | No | No | Current |
| 0186-5020-54 | 00186502054 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54) | 2001-03-19 | 0000-00-00 | No | No | Current |
| 0186-5020-82 | 00186502082 | 1000 in 1 BOTTLE | Historical |