Naproxen and esomeprazole magnesium
- Product NDC
- 85509-1438
- 11-digit product format
- 855091438
- Labeler code
- 85509
- Product ID
- 85509-1438_4c25c053-eadd-e346-e063-6394a90afe42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen and esomeprazole magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA217738
- Marketing category
- ANDA
- Marketing start
- 2023-10-11
- Substance
- ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- Active strength
- 20; 500 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | |
| A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217738-001 | AB |
| A217738-002 | 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 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | 9b2671bbb829… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217738-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217738-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | 2023-10-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217738-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217738-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217738-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217738-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217738-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217738-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217738-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217738-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217738-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217738-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217738-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217738-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217738-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217738-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217738-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217738-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217738-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217738-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217738-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217738-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217738-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217738-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217738-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217738-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217738-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217738-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217738-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A217738-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217738-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217738-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217738-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A217738-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217738-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A217738-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217738-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217738-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217738-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217738-002 | AB | 1 | 9b2671bbb829… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217738-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217738-002 | AB | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen and esomeprazole magnesium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAPROXEN | 20 mg/1 |
| ESOMEPRAZOLE MAGNESIUM | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 57Y76R9ATQ | Internal UNII lookup |
| R6DXU4WAY9 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 994008 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4c25c106-b5ca-079f-e063-6394a90a4978 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 8 | 20171212 |
| 094c6751-235c-4d12-acee-2baf94f676f4 | Product name | 1 | 20151116 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85509-1438-1 | Naproxen and esomeprazole magnesium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 1 | |
| 85509-1438-3 | Naproxen and esomeprazole magnesium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | 1 | |
| 85509-1438-6 | Naproxen and esomeprazole magnesium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 1 | |
| 85509-1438-9 | Naproxen and esomeprazole magnesium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 85509-1438-1 | EA - Each | 85509-1438 | 4f3708dc-ecfb-408b-b1dc-dcaaf5d86257 | 1 | 2026-04-20 |
| 85509-1438-3 | EA - Each | 85509-1438 | 6bc8b8b4-9705-4a2d-b269-408b459c10d5 | 1 | 2026-04-20 |
| 85509-1438-6 | EA - Each | 85509-1438 | 4c7c450d-359c-4e15-a85f-79cb9c79a209 | 1 | 2026-04-20 |
| 85509-1438-9 | EA - Each | 85509-1438 | eb7c1ff3-c208-4169-ad16-0b166c303a12 | 1 | 2026-04-20 |
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 |
|---|---|---|---|---|---|---|
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Proficient Rx LP | cfd4ef00-cfc4-4794-99fe-faa45eb2f617 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 217738 ANDA217738 |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | PHOENIX RX LLC | 4c25c106-b5ca-079f-e063-6394a90a4978 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 217738 ANDA217738 85509-1438 |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc | 470496f5-a71d-40b2-bf11-3a8d3d790962 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | 217738 ANDA217738 |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ScieGen Pharmaceuticals, Inc | 167340c2-1234-4d00-b4e2-cccf3d270fda | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | 217738 ANDA217738 |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | f3a3eea2-f6b3-4559-8536-26c1125df3e1 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | 217738 ANDA217738 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 994008 | naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet | PSN | 4c25c106-b5ca-079f-e063-6394a90a4978 | 1 |
| 994008 | esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral Tablet | SCD | 4c25c106-b5ca-079f-e063-6394a90a4978 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85509-1438-1 | 85509143801 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-1) | 2026-03-03 | No | No | Current |
| 85509-1438-3 | 85509143803 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-3) | 2026-03-03 | No | No | Current |
| 85509-1438-6 | 85509143806 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-6) | 2026-03-03 | No | No | Current |
| 85509-1438-9 | 85509143809 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-9) | 2026-03-03 | No | No | Current |