Naproxen

Product NDC
50844-271
11-digit product format
508440271
Labeler code
50844
Product ID
50844-271_785c9c93-2a92-4405-ae16-e3720ad506ad
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
ANDA079096
Marketing category
ANDA
Marketing start
2019-09-12
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50844-271DDiscontinued by firm2026-08-03
excluded packagepackage50844-27150844-271-43DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 24 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct50844-271DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50844-27150844-271-43DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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
A079096-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2008-12-16

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 UTC2026-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique MediproxenNAPROXEN SODIUMSportpharm LLCf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2026-04-24WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a0c910-7dd7-6a42-e063-6394a90a491c2026-01-13WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a00020-173b-a4a1-e063-6294a90ae3992026-01-13WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMVALU MERCHANDISERS COMPANY12748345-0d79-d6f8-e063-6394a90ab6c62025-12-11WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMVALU MERCHANDISERS COMPANY1274889d-803c-d7fd-e063-6394a90ab9a82025-12-11WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMChain Drug Marketing Associationd9e72c3f-addc-4391-a7a4-2680a3e7f5c42025-12-10WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMChain Drug Marketing Association2ee83008-c012-48d6-9479-65e7d6f50f4c2025-12-10WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHarris Teeter27938b08-ff37-4587-aa81-5ec3ef21a28a2025-12-09WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
CAREALL NaproxenNAPROXEN SODIUMNew World Imports, Inc.d9a0c6e7-a70e-479a-9737-e81a2887c7782025-12-01WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
CAREALL Naproxen SodiumNAPROXEN SODIUMNew World Imports, Inc.3952324e-77f4-4117-a97a-ab56511300582025-12-01WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Medique at Home MediproxenNAPROXEN SODIUMUnifirst First Aid Corporationb591ba4f-d7d3-4c81-e053-2995a90a7c6e2025-09-09WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Medique MediproxenNAPROXEN SODIUMUnifirst First Aid Corporationf6261d45-df1f-483b-b013-3cd6f78d9d432025-09-08WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMAMERIFOODS TRADING COMPANYf6dd2150-1643-18ff-e053-6294a90a422b2025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMMarc Glassman, Inc.684e03b6-74eb-4374-a512-1c01ea216b512025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMMarc Glassman, Inc.eeda0edf-7054-42aa-af8e-4df38b918f812025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMCHAIN DRUG MARKETING ASSOCIATION, INC.84b9e9a4-b805-420e-83be-ebe98776d1ee2025-06-20WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
NAPROXEN SODIUMNAPROXEN SODIUMAAA Pharmaceutical, Inc.5ea3217d-845d-4781-b849-6b00babdc2142025-06-17WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMFSA STORE INC.f4326f99-142b-0b70-e053-2995a90ac9512025-06-17WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHarris Teeter38543976-ccbe-4af9-b01d-ae102452d4182025-05-21WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMCHAIN DRUG MARKETING ASSOCIATION, INC.04245a78-228e-439f-8ffb-9d9bc56c7bb72025-05-20WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-271-435084402714360 POUCH in 1 CARTON (50844-271-43) > 1 TABLET in 1 POUCH60 pouch2019-09-120000-00-00NoNoCurrent