Home NDC 69784-505 NAPROXEN
Product NDC 69784-505
11-digit product format 697840505
Labeler code 69784
Product ID 69784-505_e7975860-648a-454a-b324-9d7824f92521
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naproxen
Dosage form TABLET
Route ORAL
Labeler Woodward Pharma Services LLC
Application NDA017581
Marketing category NDA
Marketing start 2018-10-15
Marketing end 0000-00-00
Substance NAPROXEN
Active strength 500 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 8 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69784-505-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…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 69784-505-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…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 69784-505-01 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 69784-505-01 I Inactivated by FDA bd6a592717d7…303034d00443…
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 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2024-04-13 These highlights do not include all the information needed to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM safely and effectively. See full prescribing information for NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM. NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen delayed-release tablets), NAPROXEN SODIUM (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976 2024-01-30 These highlights do not include all the information needed to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM safely and effectively. See full prescribing information for NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM. NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen delayed-release tablets), NAPROXEN SODIUM (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976 2022-07-30 These highlights do not include all the information needed to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM safely and effectively. See full prescribing information for NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM. NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen delayed-release tablets), NAPROXEN SODIUM (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976 2022-01-28 These highlights do not include all the information needed to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM safely and effectively. See full prescribing information for NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM. NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen delayed-release tablets), NAPROXEN SODIUM (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69784-505 NAPROXEN TABLET EC-NAPROXEN (NAPROXEN) TABLET, DELAYED RELEASE NAPROXEN SODIUM DS (NAPROXEN SODIUM) TABLET [WOODWARD PHARMA SERVICES LLC] 5 Legacy NDC 20240415_0728935b-19fc-4a10-aeba-29c42ce7f472.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69784-505-01 69784050501 100 TABLET in 1 BOTTLE, PLASTIC (69784-505-01) 100 tablet 2018-10-15 0000-00-00 No No Current