Home NDC 82804-261 Oxaprozin
Product NDC 82804-261
11-digit product format 828040261
Labeler code 82804
Product ID 82804-261_e3fbea8c-bc0d-4dcd-a14e-a4575dceeea6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxaprozin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA075855
Marketing category ANDA
Marketing start 2001-01-31
Substance OXAPROZIN
Active strength 600 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 2026-12-31
Current FDA listing Yes 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 A075855-001 OXAPROZIN OXAPROZIN 600MG TABLET / ORAL AB RS 2001-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075855-001 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 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075855-001 OXAPROZIN 600MG TABLET / ORAL AB 2001-01-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxaprozin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXAPROZIN 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MHJ80W9LRB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312132 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 82804-261-60 Oxaprozin 60 in 1 BOTTLE TABLET, FILM COATED 60 1
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxaprozin OXAPROZIN ST MARY'S MEDICAL PARK PHARMACY e881dca6-004e-1c3e-e053-2a95a90a02ab 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075855 application number: ANDA075855 Oxaprozin OXAPROZIN Proficient Rx LP e3fbea8c-bc0d-4dcd-a14e-a4575dceeea6 2025-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075855 application number: ANDA075855 ndc (product): 82804-261 Oxaprozin OXAPROZIN Dr. Reddy's Laboratories Limited da457b34-ca08-60df-045b-1ae80d2f7e71 2025-05-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075855 application number: ANDA075855 Oxaprozin OXAPROZIN Direct_Rx 284ce161-0a4a-8999-e063-6394a90aa60a 2024-12-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075855 application number: ANDA075855 Oxaprozin OXAPROZIN Bryant Ranch Prepack dcb85e40-3427-4e56-910d-c1b07bb5c0fa 2024-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075855 application number: ANDA075855
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82804-261-60 82804026160 60 TABLET, FILM COATED in 1 BOTTLE (82804-261-60) 2025-12-12 No No Current