Home NDC 65862-516 Naproxen Sodium
Product NDC 65862-516
11-digit product format 658620516
Labeler code 65862
Product ID 65862-516_a4659cf5-a74b-42b3-968b-a8e4f14f94aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
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 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-516 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 65862-516 65862-516-22 UNFINISHED Active or certified unfinished drug listing 2026-10-05
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-516-22 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-516-22 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-516-22 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-516-22 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-516-22 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-516-22 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-516-22 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-516-22 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-516-22 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-516-22 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-516-22 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-516-22 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-516-22 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-516-22 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-516-22 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-516-22 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 65862-516-22 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 65862-516-22 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 65862-516-22 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 65862-516-22 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 65862-516-22 5b2001dcd8f5…54b53d4dc9e4…
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 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849398 Internal RxNorm lookup 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 65862-516-01 Naproxen Sodium 100 in 1 BOTTLE TABLET, FILM COATED 100 12 65862-516-05 Naproxen Sodium 500 in 1 BOTTLE TABLET, FILM COATED 500 12 65862-516-26 Naproxen Sodium 2500 in 1 BOTTLE TABLET, FILM COATED 2500 12 65862-516-30 Naproxen Sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-516 NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 Current NDC, Legacy NDC, 4 package rows 20241225_37b264f9-b46d-4635-8fab-246b1e08b653.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 ndc (product): 65862-516 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
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 65862-516-01 65862051601 100 TABLET, FILM COATED in 1 BOTTLE (65862-516-01) 2011-10-31 0000-00-00 No No Current 65862-516-05 65862051605 500 TABLET, FILM COATED in 1 BOTTLE (65862-516-05) 2011-10-31 0000-00-00 No No Current 65862-516-22 65862051622 2000 TABLET, FILM COATED in 1 BAG (65862-516-22) 31-OCT-11 Current 65862-516-26 65862051626 2500 TABLET, FILM COATED in 1 BOTTLE (65862-516-26) 2011-10-31 0000-00-00 No No Current 65862-516-30 65862051630 30 TABLET, FILM COATED in 1 BOTTLE (65862-516-30) 2011-10-31 0000-00-00 No No Current