Home NDC 50844-417-19 Naproxen Sodium
Product NDC 50844-417
Requested package NDC 50844-417-19
11-digit product format 508440417
Labeler code 50844
Product ID 50844-417_89d3ed35-e75c-41d8-aa99-57cc1fd866d2
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application ANDA204872
Marketing category ANDA
Marketing start 2017-02-01
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 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204872-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204872-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2017-01-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204872-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2017-01-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 cb3db0bc1861…
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 · 28 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen NAPROXEN SODIUM Preferred Pharmaceuticals, Inc. 20eb9d9f-11df-464f-a1b0-949f8fda4042 2026-07-28 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Back and Muscle Pain NAPROXEN SODIUM CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 4039504c-e612-4503-854a-62ee06780956 2026-07-13 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Lidl US LLC 3d01220c-c5ec-4604-8cef-9ecb807ccd53 2026-06-22 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Rite Aid Corporation 134e5ec6-c42a-43b6-adf2-2d7546875ead 2026-06-19 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Headache Pain NAPROXEN SODIUM L.N.K. International, Inc. 6161b881-f422-47ae-86ba-a28d669bce79 2026-06-18 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Family Dollar Services Inc d9c63e1f-c2ad-434b-8a21-7fff21b7477b 2026-06-03 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Rite Aid Corporation e6277515-c606-4535-9c29-08cade045aee 2026-05-14 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Back and Muscle Pain NAPROXEN SODIUM L.N.K. International, Inc. 68944663-0dc0-4d3a-a36b-019061bdbfa0 2026-03-09 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 AnaDent NAPROXEN SODIUM Belmora LLC 236674db-da4d-415c-a160-7086eaf5bff5 2026-03-03 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM L.N.K. International, Inc. 717518e4-2537-4229-b765-c6acfe963d4b 2026-02-25 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (package): 50844-417-19 ndc (product): 50844-417 ndc11 (package): 50844041719 Naproxen Sodium NAPROXEN SODIUM Better Living Brands, LLC 3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c041 2026-02-13 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Back and Muscle Pain NAPROXEN SODIUM Rite Aid Corporation e162bd50-f94a-4c76-8f1b-62114f283809 2026-02-11 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Flanax Menstrual Pain Reliever NAPROXEN SODIUM Belmora LLC 2b4135b3-389c-46e2-ae86-7674c2ab9a32 2026-01-27 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Flanax NAPROXEN SODIUM Belmora LLC 2c099d45-f03a-4161-a6af-8fe5965f2748 2026-01-06 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 All Day Pain Relief NAPROXEN SODIUM WALMART INC. c4909e43-57ba-44bc-a234-a02cc884891c 2025-12-11 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 24/7 Life by 7-Eleven Naproxen Sodium NAPROXEN SODIUM TABLET, FILM COATED Lil' Drug Store Products, Inc. 44716954-006a-4c56-e063-6294a90a0f14 2025-11-25 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Athlete's Needs Inc d5984c9d-3941-45d6-8392-87564b2faae0 2025-11-15 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Better Living Brands, LLC 43745d42-f859-4168-a2dd-2c8ae47ae590 2025-10-28 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Family Dollar Services Inc b6205032-f5c6-494a-8b87-adbbbc3982e7 2025-10-27 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Amerisource Bergen 1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0 2025-10-20 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872
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 220 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 849574 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 50844-417-11 Naproxen Sodium 60 in 1 CARTON TABLET, FILM COATED 60 15 50844-417-14 Naproxen Sodium 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 15 50844-417-16 Naproxen Sodium 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 15 50844-417-19 Naproxen Sodium 1 in 1 CARTON TABLET, FILM COATED 1 15 50844-417-19 Naproxen Sodium 8 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 8 15 50844-417-22 Naproxen Sodium 48 in 1 CARTON TABLET, FILM COATED 48 15 50844-417-43 Naproxen Sodium 1 in 1 POUCH TABLET, FILM COATED 1 15 50844-417-56 Naproxen Sodium 25 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 25 15 50844-417-98 Naproxen Sodium 8 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 8 15 50844-417-99 Naproxen Sodium 8 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 8 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-417 NAPROXEN SODIUM TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 13 Current NDC, Legacy NDC, 10 package rows 20250116_717518e4-2537-4229-b765-c6acfe963d4b.zip
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 50844-417-19 50844041719 1 BOTTLE, PLASTIC in 1 CARTON (50844-417-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2017-02-01 0000-00-00 No No Current