Home NDC 25000-141 Naproxen Sodium
Product NDC 25000-141
11-digit product format 250000141
Labeler code 25000
Product ID 25000-141_1e0b6883-f02c-4259-b905-9716dd72bcbf
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium, Coated Tablets
Dosage form TABLET
Route ORAL
Labeler MARKSANS PHARMA LIMITED
Application ANDA090545
Marketing category ANDA
Marketing start 2011-05-28
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 2026-12-31
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 A090545-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16
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 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 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 cb3db0bc1861…
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 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25000-141 NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED] 8 Current NDC, Legacy NDC, 10 package rows 20230615_48cb1363-ff12-40ee-a87a-2252dfbf8ff7.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 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25000-141-02 25000014102 160 CARTON in 1 BOX (25000-141-02) / 1 BOTTLE in 1 CARTON / 24 TABLET in 1 BOTTLE 160 carton 2011-05-28 0000-00-00 No No Current 25000-141-14 25000014114 1000 TABLET in 1 BOTTLE, PLASTIC (25000-141-14) 1000 tablet 2011-05-28 0000-00-00 No No Current 25000-141-26 25000014126 2 BAG in 1 BOX (25000-141-26) / 1600 TABLET in 1 BAG 2 bag 2011-05-28 0000-00-00 No No Current 25000-141-30 25000014130 6 BAG in 1 BOX (25000-141-30) / 6500 TABLET in 1 BAG 6 bag 2011-05-28 0000-00-00 No No Current 25000-141-43 25000014143 10 TABLET in 1 BOTTLE (25000-141-43) 10 tablet 2011-05-28 0000-00-00 No No Current 25000-141-98 25000014198 1 BAG in 1 BOX (25000-141-98) / 32165 TABLET in 1 BAG 1 bag 2011-05-28 0000-00-00 No No Current