Home NDC 53002-3112-5 naproxen
Product NDC 53002-3112
Requested package NDC 53002-3112-5
11-digit product format 530023112
Labeler code 53002
Product ID 53002-3112_09c60496-bf1e-406d-8b44-13547628ddd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naproxen
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA091305
Marketing category ANDA
Marketing start 2016-07-05
Marketing end 0000-00-00
Substance NAPROXEN
Active strength 500 mg/1
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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A091305-001 NAPROXEN NAPROXEN 250MG TABLET / ORAL 2011-08-24 A091305-002 NAPROXEN NAPROXEN 375MG TABLET / ORAL 2011-08-24 A091305-003 NAPROXEN NAPROXEN 500MG TABLET / ORAL 2011-08-24
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 · 126 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 2026-08-18 06:07:40 2026-07 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091305-002 NAPROXEN 375MG TABLET / ORAL 2011-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091305-003 NAPROXEN 500MG TABLET / ORAL 2011-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091305-001 NAPROXEN 250MG TABLET / ORAL 2011-08-24 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-3112-1 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 53002-3112-2 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 53002-3112-3 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 53002-3112-4 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 53002-3112-5 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 53002-3112-6 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 53002-3112-1 2023-06-07 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 53002-3112-2 2023-06-07 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 53002-3112-3 2023-06-07 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 53002-3112-4 2023-06-07 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 53002-3112-5 2023-06-07 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 53002-3112-6 2023-06-07 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 53002-3112-1 2023-01-30 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 53002-3112-2 2023-01-30 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 53002-3112-3 2023-01-30 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 53002-3112-4 2023-01-30 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 53002-3112-5 2023-01-30 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 53002-3112-6 2023-01-30 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 53002-3112-1 2020-12-15 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 53002-3112-2 2020-12-15 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 53002-3112-4 2020-12-15 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 53002-3112-5 2020-12-15 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 53002-3112-6 2020-12-15 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 53002-3112-1 2020-01-31 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 53002-3112-2 2020-01-31 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 53002-3112-4 2020-01-31 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 53002-3112-5 2020-01-31 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 53002-3112-6 2020-01-31 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-3112 NAPROXEN TABLET [RPK PHARMACEUTICALS, INC.] 13 Legacy NDC, 6 package rows 20230609_a7f0801c-96de-4d28-b221-627372f2bebd.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join naproxen NAPROXEN Cipla USA Inc. a9549a47-3fa4-4a2b-95ac-b00e43aedae7 2023-01-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091305 application number: ANDA091305 Naproxen NAPROXEN Exelan Pharmaceuticals, Inc. 46dbdb95-a0d0-4410-8d64-b22763b12af7 2020-08-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091305 application number: ANDA091305 Naproxen NAPROXEN Aphena Pharma Solutions - Tennessee, LLC e2347581-90da-429a-b17c-cffd0039fb86 2017-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091305 application number: ANDA091305
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 53002-3112-5 53002311205 30 TABLET in 1 BOTTLE (53002-3112-5) 30 tablet 2018-10-01 0000-00-00 No No Current