Naproxen Sodium

Product NDC
0363-0975
Requested package NDC
0363-0975-18
11-digit product format
003630975
Labeler code
0363
Product ID
0363-0975_657ad344-7357-44bc-8576-811829eb253e
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
NDA021920
Marketing category
NDA
Marketing start
2018-02-06
Marketing end
2021-12-30
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-09750363-0975-18DDiscontinued by firm2026-08-10

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021920-001NAPROXEN SODIUMNAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021920-001100223442026-03-03U-1731Drug product2018-07-23
N021920-001100223442026-03-03U-1732Drug product2018-07-23
N021920-001100289252026-03-03U-1731Drug product2018-07-24
N021920-001100289252026-03-03U-1732Drug product2018-07-24
N021920-001110902802026-03-03U-1731Drug product2021-08-24
N021920-001110902802026-03-03U-1732Drug product2021-08-24
N021920-00196939782026-03-03Drug product2017-11-13
N021920-00196939792026-03-03Drug product2017-11-13

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021920-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORALRLD, RS2006-02-17cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 8 · 313 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021920-001100223442026-03-03U-1731Drug product2018-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021920-001100223442026-03-03U-1732Drug product2018-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021920-001100289252026-03-03U-1731Drug product2018-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021920-001100289252026-03-03U-1732Drug product2018-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021920-001110902802026-03-03U-1731Drug product2021-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021920-001110902802026-03-03U-1732Drug product2021-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021920-00196939782026-03-03Drug product2017-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021920-00196939792026-03-03Drug product2017-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-001100223442026-03-03U-1731Drug product2018-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-001100223442026-03-03U-1732Drug product2018-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-001100289252026-03-03U-1731Drug product2018-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-001100289252026-03-03U-1732Drug product2018-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-001110902802026-03-03U-1731Drug product2021-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-001110902802026-03-03U-1732Drug product2021-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-00196939782026-03-03Drug product2017-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021920-00196939792026-03-03Drug product2017-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021920-001100223442026-03-03U-1731Drug product2018-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021920-001100223442026-03-03U-1732Drug product2018-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021920-001100289252026-03-03U-1731Drug product2018-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021920-001100289252026-03-03U-1732Drug product2018-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021920-001110902802026-03-03U-1731Drug product2021-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021920-001110902802026-03-03U-1732Drug product2021-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021920-00196939782026-03-03Drug product2017-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021920-00196939792026-03-03Drug product2017-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-001100223442026-03-03U-1731Drug product2018-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-001100223442026-03-03U-1732Drug product2018-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-001100289252026-03-03U-1731Drug product2018-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-001100289252026-03-03U-1732Drug product2018-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-001110902802026-03-03U-1731Drug product2021-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-001110902802026-03-03U-1732Drug product2021-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-00196939782026-03-03Drug product2017-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021920-00196939792026-03-03Drug product2017-11-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-001100223442026-03-03U-1731Drug product2018-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-001100223442026-03-03U-1732Drug product2018-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-001100289252026-03-03U-1731Drug product2018-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-001100289252026-03-03U-1732Drug product2018-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-001110902802026-03-03U-1731Drug product2021-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-001110902802026-03-03U-1732Drug product2021-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-00196939782026-03-03Drug product2017-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021920-00196939792026-03-03Drug product2017-11-13b8a1b40f171c…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
naproxen sodiumNAPROXEN SODIUMBionpharma Inc.9343c79f-9994-4599-bcfe-0a93e49d726e2026-05-12WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMAmazon.com Services LLC04a298dc-c525-8198-e063-6294a90a6f962026-04-27WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
naproxen sodiumNAPROXEN SODIUMBionpharma Inc.ba4f927a-4bbe-0d87-e053-2995a90a8c202026-04-20WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMMEIJER DISTRIBUTION INC89f82399-9f71-49dd-8710-b60f346c576c2025-12-12WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMTARGET Corporation36bf8594-9303-c816-e063-6294a90af7052025-12-08WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
AleveNAPROXEN SODIUMBayer HealthCare LLC.1266393e-b55e-4e34-9710-0b87209f41582025-12-04WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Aleve Easy Open Arthritis CapNAPROXEN SODIUMBayer HealthCare LLC.3b5442c6-c6e1-4df3-8cec-40bbb4ec469f2025-12-04WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMAlbertsons Companiesf9df7495-9da7-8838-e053-6294a90a6fda2024-09-30WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMAMERISOURCE BERGEN16b3bbee-4881-b439-e063-6394a90a7c8f2024-04-22WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMBionpharma Inc.3e10256f-0a5f-49e4-9518-a72b10490f892023-12-27WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMVALU MERCHANDISERS COMPANYfed305f1-e32d-e1ff-e053-6294a90a273d2023-10-03WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMRite Aid Corporationa359c47e-e2b4-5560-e053-2a95a90a28442023-03-03WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMKROGER COMPANY7487e685-ea64-43a2-9a4e-f5278840be042022-12-29WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMWal-Mart Stores, Inc.073ecef7-f5b1-4ee0-98bc-82972e3d84f92022-12-29WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMWALGREEN COMPANYa13bd208-f29f-1cbc-e053-2995a90a08ba2022-12-29WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMHEBdf8ea301-c48b-4da4-9e8e-5c69cac6cba72022-12-29WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMTOP CARE (Topco Associates LLC)c62b7fa0-5ae9-276c-e053-2995a90ade252022-12-29WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMCHAIN DRUG MARKETING ASSOCIATION INC.c482db41-b115-c24f-e053-2a95a90a29472022-12-21WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMWALGREEN COMPANY462a7e41-b899-4e08-8113-b48ece0ad8d82022-03-17WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920
Naproxen SodiumNAPROXEN SODIUMDISCOUNT DRUG MART, INC.b00c0e86-4c0b-45bf-948f-824ea0f09e392022-03-16WarningsExact identifier
application applno (NDA): 021920
application number: NDA021920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0975-1800363097518180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0975-18) 2018-02-062021-12-30NoNoCurrent