Home NDC 53746-191 Naproxen Sodium (NSAID)
Product NDC 53746-191
11-digit product format 537460191
Labeler code 53746
Product ID 53746-191_9cc39ab5-450a-4e0b-948d-fdebd66c0f6f
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA079096
Marketing category ANDA
Marketing start 2009-11-25
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 43 .
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 A079096-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16
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 · 43 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 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079096-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2008-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079096-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2008-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 f41ea6bd6efb…
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 (NSAID)
Brand name suffix Fever Reducer/ Pain Reliever
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-191-05 Naproxen Sodium (NSAID)Fever Reducer/ Pain Reliever 500 in 1 BOTTLE TABLET 500 13 53746-191-08 Naproxen Sodium (NSAID)Fever Reducer/ Pain Reliever 8 in 1 VIAL TABLET 8 13 53746-191-24 Naproxen Sodium (NSAID)Fever Reducer/ Pain Reliever 24 in 1 BOTTLE TABLET 24 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-191 NAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER (NAPROXEN SODIUM) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 13 Current NDC, Legacy NDC, 3 package rows 20240101_0bb41b8c-6031-4e96-95e1-31adab811837.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 2 of 2 · 31 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 53746-191-05 53746019105 500 TABLET in 1 BOTTLE (53746-191-05) 500 tablet 2009-11-25 0000-00-00 No No Current 53746-191-08 53746019108 8 TABLET in 1 VIAL (53746-191-08) 8 tablet 2009-11-25 0000-00-00 No No Current 53746-191-24 53746019124 24 TABLET in 1 BOTTLE (53746-191-24) 24 tablet 2009-11-25 0000-00-00 No No Current