Home NDC 42494-405 NAPROXEN
Product NDC 42494-405
11-digit product format 424940405
Labeler code 42494
Product ID 42494-405_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 500 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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 N017581-002 NAPROSYN 250MG TABLET / ORAL RLD, Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N017581-003 NAPROSYN 375MG TABLET / ORAL RLD, Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N017581-004 NAPROSYN 500MG TABLET / ORAL AB RLD, RS 1982-04-15 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 N017581-004 AB 1 f41ea6bd6efb…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 42494-405 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