Home NDC 43598-495-01 Naproxen sodium
Product NDC 43598-495
Requested package NDC 43598-495-01
11-digit product format 435980495
Labeler code 43598
Product ID 43598-495_b0e85222-c6c4-647a-6fd1-e38676517e2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
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 44 .
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 · 88 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 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078486-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078486-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-07-26 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-495-01 Naproxen sodium 100 in 1 BOTTLE TABLET, FILM COATED 100 12 43598-495-05 Naproxen sodium 500 in 1 BOTTLE TABLET, FILM COATED 500 12 43598-495-10 Naproxen sodium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 12 43598-495-30 Naproxen sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-495 NAPROXEN SODIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.] 10 Current NDC, Legacy NDC, 4 package rows 20240724_37de42a6-701b-7f6e-e631-519e2ea78b54.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43598-495-01 43598049501 100 TABLET, FILM COATED in 1 BOTTLE (43598-495-01) 2016-04-26 0000-00-00 No No Current