Home NDC 85509-1495 Naproxen sodium
Product NDC 85509-1495
11-digit product format 855091495
Labeler code 85509
Product ID 85509-1495_4b97c5af-891e-98f4-e063-6394a90ab4ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PHOENIX RX LLC
Application ANDA078486
Marketing category ANDA
Marketing start 2016-04-26
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078486-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 A078486-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Naproxen sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN SODIUM 550 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9TN87S3A3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849431 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85509-1495-3 Naproxen sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 2 85509-1495-6 Naproxen sodium 60 in 1 BOTTLE TABLET, FILM COATED 60 2 85509-1495-9 Naproxen sodium 90 in 1 BOTTLE TABLET, FILM COATED 90 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen sodium NAPROXEN SODIUM PHOENIX RX LLC 47d18804-d8d6-8248-e063-6394a90a48a9 2026-02-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078486 application number: ANDA078486 ndc (product): 85509-1495 Naproxen sodium NAPROXEN SODIUM A-S Medication Solutions 8181bb7a-d917-4388-bcb0-a74671b07b06 2026-02-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078486 application number: ANDA078486 Naproxen sodium NAPROXEN SODIUM Dr. Reddy's Laboratories Inc. 37de42a6-701b-7f6e-e631-519e2ea78b54 2025-06-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078486 application number: ANDA078486 Naproxen sodium NAPROXEN SODIUM Quality Care Products, LLC e2ed5556-8109-4002-bf8b-827518a84ea4 2024-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078486 application number: ANDA078486 Naproxen sodium NAPROXEN SODIUM Bryant Ranch Prepack 42f6a3a0-5a1e-40ca-8949-b8870dd95d2e 2024-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078486 application number: ANDA078486
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85509-1495-3 85509149503 30 TABLET, FILM COATED in 1 BOTTLE (85509-1495-3) 2026-01-07 No No Current 85509-1495-6 85509149506 60 TABLET, FILM COATED in 1 BOTTLE (85509-1495-6) 2026-01-07 No No Current 85509-1495-9 85509149509 90 TABLET, FILM COATED in 1 BOTTLE (85509-1495-9) 2026-01-07 No No Current