Home NDC 68071-3223 Naproxen Sodium
Product NDC 68071-3223
11-digit product format 680713223
Labeler code 68071
Product ID 68071-3223_83869a45-8851-5230-e053-2991aa0a74f2
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA090545
Marketing category ANDA
Marketing start 2012-05-01
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 220 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 57 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-3223-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-3223-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-3223-3 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-3223-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-3223-3 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-3223-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-3223-3 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-3223-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-3223-3 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-3223-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-3223-3 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-3223-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-3223-3 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-3223-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-3223-3 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-3223-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-3223-3 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-3223-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68071-3223-3 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68071-3223-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-3223-3 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-3223-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-3223-3 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-3223-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-3223-3 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-3223-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-3223-3 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-3223-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-3223-3 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-3223-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68071-3223-3 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68071-3223-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68071-3223-3 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68071-3223-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68071-3223-3 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68071-3223-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68071-3223-3 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68071-3223-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…
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…
FDA-Initiated Inactive NDC Indexing# 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.