Home NDC 71511-701 Naprosyn
Product NDC 71511-701
11-digit product format 715110701
Labeler code 71511
Product ID 71511-701_8ae1c41c-a532-4878-bc44-814b2061fdd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form SUSPENSION
Route ORAL
Labeler Athena Bioscience, LLC
Application NDA018965
Marketing category NDA
Marketing start 2018-01-01
Marketing end 0000-00-00
Substance NAPROXEN
Active strength 125 mg/5mL
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71511-701-16 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71511-701-16 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71511-701-16 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71511-701-16 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71511-701-16 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71511-701-16 cdf11ea48f46…ba0047e9e063…
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 N018965-001 NAPROSYN NAPROXEN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018965-001 AB
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 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen NAPROXEN Acella Pharmaceuticals, LLC 7e6f03fb-4b36-4418-9684-f45637abbb78 2026-01-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018965 application number: NDA018965
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71511-701-16 71511070116 473 mL in 1 BOTTLE, PLASTIC (71511-701-16) 473 ml 2018-01-01 0000-00-00 No No Current