Naproxen and Esomeprazole Magnesium
- Product NDC
- 0378-4386
- 11-digit product format
- 003784386
- Labeler code
- 0378
- Product ID
- 0378-4386_34e7c117-7512-442e-bd87-059b09180509
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naproxen and esomeprazole magnesium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204920
- Marketing category
- ANDA
- Marketing start
- 2021-11-22
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- Active strength
- 20 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 0378-4386 | D | Discontinued by firm | 2026-09-09 | ||
| excluded package | package | 0378-4386 | 0378-4386-91 | D | Discontinued by firm | 2026-09-09 |
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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 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 | 0378-4386-91 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | ||
| A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 |
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 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2021-07-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204920-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204920-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2021-07-20 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204920-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204920-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204920-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A204920-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204920-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A204920-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A204920-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A204920-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204920-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A204920-002 | AB | 1 | 782e0a99824c… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204920-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204920-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204920-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204920-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204920-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204920-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A204920-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A204920-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A204920-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A204920-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204920-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204920-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A204920-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A204920-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A204920-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A204920-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204920-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204920-002 | AB | 1 | cb3db0bc1861… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-4386-91 | EA - Each | 0378-4386 | 2bd05408-4b4b-40f7-b6d6-28f29771a46e | 1 | 2021-12-08 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-4386-91 | 00378438691 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4386-91) | 2021-11-22 | 0000-00-00 | No | No | Current |