Home NDC 51655-457 Naproxen
Product NDC 51655-457
11-digit product format 516550457
Labeler code 51655
Product ID 51655-457_49edbcc6-3934-c4fa-e063-6294a90a3e48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form TABLET
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA074140
Marketing category ANDA
Marketing start 2023-05-04
Substance NAPROXEN
Active strength 500 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 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 · 35 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51655-457-26 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51655-457-25 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51655-457-52 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51655-457-20 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51655-457-26 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51655-457-25 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51655-457-52 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51655-457-20 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51655-457-26 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51655-457-25 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51655-457-52 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51655-457-20 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51655-457-26 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51655-457-25 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51655-457-52 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51655-457-20 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51655-457-52 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51655-457-25 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51655-457-26 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51655-457-20 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51655-457-52 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51655-457-25 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51655-457-26 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51655-457-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51655-457-52 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51655-457-25 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51655-457-26 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51655-457-20 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074140-001 NAPROXEN NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 A074140-002 NAPROXEN NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 A074140-003 NAPROXEN NAPROXEN 500MG TABLET / ORAL AB 1993-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074140-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074140-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074140-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57Y76R9ATQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198014 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 51655-457-20 2025-04-10 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976 51655-457-25 2025-04-10 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976 51655-457-26 2025-04-10 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976 51655-457-52 2025-04-10 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976 51655-457-20 2025-01-30 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976 51655-457-25 2025-01-30 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976 51655-457-26 2025-01-30 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976 51655-457-52 2025-01-30 These highlights do not include all the information needed to use NAPROXEN TABLETS, safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51655-457-20 Naproxen 20 in 1 BOTTLE, PLASTIC TABLET 20 4 51655-457-25 Naproxen 60 in 1 BOTTLE, PLASTIC TABLET 60 4 51655-457-26 Naproxen 90 in 1 BOTTLE, PLASTIC TABLET 90 4 51655-457-52 Naproxen 30 in 1 BOTTLE, PLASTIC TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-457 NAPROXEN TABLET [NORTHWIND PHARMACEUTICALS, LLC] 3 Current NDC, 4 package rows 20250410_fb07a76b-98ce-85dd-e053-6294a90aa6a8.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 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen NAPROXEN Redpharm Drug 52503536-593e-808b-e063-6294a90a737f 2026-05-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074140 application number: ANDA074140 Naproxen NAPROXEN REMEDYREPACK INC. 12202ef3-c65e-45a6-88ed-5d945d8fd41c 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074140 application number: ANDA074140 Naproxen NAPROXEN Northwind Health Company, LLC 0de6d673-fa76-e9c0-e063-6394a90a9ded 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074140 application number: ANDA074140 Naproxen NAPROXEN Northwind Health Company, LLC fb07a76b-98ce-85dd-e053-6294a90aa6a8 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074140 application number: ANDA074140 ndc (product): 51655-457
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51655-457-20 51655045720 20 TABLET in 1 BOTTLE, PLASTIC (51655-457-20) 20 tablet 2023-07-03 No No Current 51655-457-25 51655045725 60 TABLET in 1 BOTTLE, PLASTIC (51655-457-25) 60 tablet 2023-05-04 No No Current 51655-457-26 51655045726 90 TABLET in 1 BOTTLE, PLASTIC (51655-457-26) 90 tablet 2023-06-15 No No Current 51655-457-52 51655045752 30 TABLET in 1 BOTTLE, PLASTIC (51655-457-52) 30 tablet 2023-05-04 No No Current