Home NDC 70518-4439 Naproxen
Product NDC 70518-4439
11-digit product format 705184439
Labeler code 70518
Product ID 70518-4439_4f0c17b4-ee4f-026c-e063-6394a90ac5c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA074140
Marketing category ANDA
Marketing start 2025-08-13
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 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 2 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4439-0 Naproxen 12 in 1 BOTTLE, PLASTIC TABLET 12 5 70518-4439-1 Naproxen 20 in 1 BOTTLE, PLASTIC TABLET 20 5 70518-4439-2 Naproxen 30 in 1 BOTTLE, PLASTIC TABLET 30 5 70518-4439-3 Naproxen 90 in 1 BOTTLE, PLASTIC TABLET 90 5 70518-4439-4 Naproxen 30 in 1 BOTTLE, PLASTIC TABLET 30 5
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 ndc (product): 70518-4439 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4439-0 70518443900 12 TABLET in 1 BOTTLE, PLASTIC (70518-4439-0) 12 tablet 2025-08-13 No No Current 70518-4439-1 70518443901 20 TABLET in 1 BOTTLE, PLASTIC (70518-4439-1) 20 tablet 2025-09-24 No No Current 70518-4439-2 70518443902 30 TABLET in 1 BOTTLE, PLASTIC (70518-4439-2) 30 tablet 2026-01-06 No No Current 70518-4439-3 70518443903 90 TABLET in 1 BOTTLE, PLASTIC (70518-4439-3) 90 tablet 2026-04-02 No No Current 70518-4439-4 70518443904 30 TABLET in 1 BOTTLE, PLASTIC (70518-4439-4) 30 tablet 2026-04-09 No No Current