Home NDC 55289-367-06 Naproxen Sodium
Product NDC 55289-367
Requested package NDC 55289-367-06
11-digit product format 552890367
Labeler code 55289
Product ID 55289-367_dee8dec8-0c62-83bc-e053-2995a90ab743
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA078432
Marketing category ANDA
Marketing start 2007-04-26
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 550 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-367 55289-367-06 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078432-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 A078432-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25
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 · 86 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 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL 2007-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL 2007-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078432-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078432-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-367 NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 27 Legacy NDC 20250322_58caec51-74aa-44b8-9638-f7cca096a54a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-367-06 55289036706 6 TABLET in 1 BOTTLE, PLASTIC (55289-367-06) 6 tablet 2010-09-22 0000-00-00 No No Current