Home NDC 71205-479 Naproxen Sodium
Product NDC 71205-479
11-digit product format 712050479
Labeler code 71205
Product ID 71205-479_397db794-027c-4a89-993e-07c208b457a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA200629
Marketing category ANDA
Marketing start 2011-10-31
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 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 A200629-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 A200629-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31
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 · 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 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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
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 71205-479-15 Naproxen Sodium 15 in 1 BOTTLE TABLET, FILM COATED 15 1 71205-479-30 Naproxen Sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71205-479-60 Naproxen Sodium 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71205-479-90 Naproxen Sodium 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-479 NAPROXEN SODIUM TABLET, FILM COATED [PROFICIENT RX LP] 1 Current NDC, Legacy NDC, 4 package rows 20201007_397db794-027c-4a89-993e-07c208b457a3.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 1c2325f7-1d65-429d-a64d-6ab075df1c20 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629 Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 0e7697ad-25c6-4405-9f9b-791633cb1ef7 2025-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629 Naproxen Sodium NAPROXEN SODIUM Aurobindo Pharma Limited 37b264f9-b46d-4635-8fab-246b1e08b653 2025-09-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629 Naproxen Sodium NAPROXEN SODIUM Proficient Rx LP 397db794-027c-4a89-993e-07c208b457a3 2020-09-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629 ndc (product): 71205-479
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 71205-479-15 71205047915 15 TABLET, FILM COATED in 1 BOTTLE (71205-479-15) 2020-09-30 0000-00-00 No No Current 71205-479-30 71205047930 30 TABLET, FILM COATED in 1 BOTTLE (71205-479-30) 2020-09-30 0000-00-00 No No Current 71205-479-60 71205047960 60 TABLET, FILM COATED in 1 BOTTLE (71205-479-60) 2020-09-30 0000-00-00 No No Current 71205-479-90 71205047990 90 TABLET, FILM COATED in 1 BOTTLE (71205-479-90) 2020-09-30 0000-00-00 No No Current