Home NDC 59115-002 Naproxen Sodium
Product NDC 59115-002
11-digit product format 591150002
Labeler code 59115
Product ID 59115-002_efde630c-d2fc-4da7-a7d1-45d9dba86b67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceutical
Application ANDA074480
Marketing category ANDA
Marketing start 1998-02-18
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 275 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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074480-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 A074480-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074480-001 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 1996-05-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074480-002 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 1998-02-18 bb7c543d1eb4…
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