Home NDC 42494-403 NAPROXEN
Product NDC 42494-403
11-digit product format 424940403
Labeler code 42494
Product ID 42494-403_64efd778-d06c-4289-95f6-ae1fbd6efd35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naproxen
Dosage form TABLET
Route ORAL
Labeler Cameron Pharmaceuticals, LLC
Application NDA017581
Marketing category NDA
Marketing start 2016-07-10
Marketing end 0000-00-00
Substance NAPROXEN
Active strength 250 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42494-403-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42494-403-05 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42494-403-05 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42494-403-05 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42494-403-05 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42494-403-05 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42494-403-05 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42494-403-05 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42494-403-05 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42494-403-05 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42494-403-05 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42494-403-05 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42494-403-05 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42494-403-05 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42494-403-05 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 42494-403-05 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 42494-403-05 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 42494-403-05 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 42494-403-05 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 42494-403-05 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 42494-403-05 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 42494-403-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017581-002 NAPROSYN NAPROXEN 250MG TABLET / ORAL RLD, Approved before 1982 N017581-003 NAPROSYN NAPROXEN 375MG TABLET / ORAL RLD, Approved before 1982 N017581-004 NAPROSYN NAPROXEN 500MG TABLET / ORAL AB RLD, RS 1982-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017581-004 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.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 N017581-004 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017581-004 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017581-004 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42494-403 NAPROXEN TABLET EC-NAPROXEN (NAPROXEN) TABLET, DELAYED RELEASE NAPROXEN SODIUM TABLET NAPROXEN SODIUM DS (NAPROXEN SODIUM) TABLET [CAMERON PHARMACEUTICALS, LLC] 2 Legacy NDC 20160813_b86b31e9-1726-414a-877e-50079c017339.zip