Naproxen
- Product NDC
- 80175-0436
- 11-digit product format
- 801750436
- Labeler code
- 80175
- Product ID
- 80175-0436_be3722bc-d822-c576-e053-2a95a90a1073
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Central Packaging
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 80175-0436 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 80175-0436 | 80175-0436-6 | I | Inactivated by FDA | 2026-08-10 |
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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 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 | 80175-0436-6 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 80175-0436-6 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 80175-0436-6 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 80175-0436-6 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 80175-0436-6 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 80175-0436-6 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 80175-0436-6 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 80175-0436-6 | 8dfbde2a14a4… | c9ff85d89658… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212517-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | |
| A212517-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | |
| A212517-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212517-001 | AB |
| A212517-002 | AB |
| A212517-003 | 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 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212517-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212517-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 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 |
|---|---|---|---|---|---|---|
| 80175-0436-6 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80175-0436 | NAPROXEN TABLET [CENTRAL PACKAGING] | 1 | Legacy NDC, 1 package rows | 20210226_bc2c6b1e-999d-91a7-e053-2a95a90a9d1a.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 |
|---|---|---|---|---|---|---|
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | 24d44eb6-921e-4150-a6b2-81f42ced32ab | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 49a00870-f580-4eb9-a95d-48fa956f147f | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals, Inc. | 9f026fd5-f996-4383-b528-841d38d3dab5 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | HAWAII REPACK, INC. | 888efc91-b4de-4691-b84c-fb871e7a6dfe | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | St. Mary's Medical Park Pharmacy | e3a3e5d2-2d1e-74d3-e053-2995a90a82bf | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | REMEDYREPACK INC. | ccd95dfc-9236-4707-a715-6a12c91519ff | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | ST. MARY'S MEDICAL PARK PHARMACY | e3a4ab4a-b109-eb5e-e053-2a95a90afddd | 2026-06-07 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 2e72de28-e62b-44e0-b17d-500d13e0bcc6 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | bbc61c0a-491a-4f50-a7bf-2ca94c771568 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Sportpharm LLC | 1c5b2bc1-26bb-4f88-bded-399263c82331 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | f18181f4-6b14-48a8-a149-e45b3360a250 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 97d6c4ef-13b1-4b0b-a15a-f0590019940d | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 852fed15-e78b-47a8-aeb4-623dfe1edad9 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | REMEDYREPACK INC. | 6bb65680-76ea-46e5-ae70-f3091e360368 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Radha Pharmaceuticals, Inc. | 1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | ScieGen Pharmaceuticals, Inc. | 81e22c1f-f94d-46e9-8b7d-72dc2518319e | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals,Inc. | c136cf75-4ad4-8634-e053-2a95a90a53a4 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | fa2fe6fd-c476-dd29-e053-6294a90a9e9e | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Northwind Health Company, LLC | db478961-d984-7c8e-e053-2995a90a8a12 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Northwind Health Company, LLC | c986ba9a-6f48-8347-e053-2a95a90aa1c1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198014 | naproxen 500 MG Oral Tablet | PSN | bc2c6b1e-999d-91a7-e053-2a95a90a9d1a | 1 |
| 198014 | naproxen 500 MG Oral Tablet | SCD | bc2c6b1e-999d-91a7-e053-2a95a90a9d1a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80175-0436-6 | 80175043606 | 60 TABLET in 1 BOTTLE (80175-0436-6) | 60 tablet | 2020-03-01 | 0000-00-00 | No | No | Current |