Home NDC 71335-0617 Oxaprozin
Product NDC 71335-0617
11-digit product format 713350617
Labeler code 71335
Product ID 71335-0617_f128ff41-2ad3-4a5b-a34c-13d6f8940f35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxaprozin
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA208633
Marketing category ANDA
Marketing start 2017-05-04
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 A208633-001 OXAPROZIN OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208633-001 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 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208633-001 OXAPROZIN 600MG TABLET / ORAL AB 2017-05-04 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0617 OXAPROZIN TABLET [BRYANT RANCH PREPACK] 9 Current NDC, Legacy NDC, 7 package rows 20231024_c157016e-0777-4ad7-89b8-487c47bb74cb.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 · 2 matching rows.
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 71335-0617-1 71335061701 30 TABLET in 1 BOTTLE (71335-0617-1) 30 tablet 2021-12-27 0000-00-00 No No Current 71335-0617-2 71335061702 20 TABLET in 1 BOTTLE (71335-0617-2) 20 tablet 2021-12-27 0000-00-00 No No Current 71335-0617-3 71335061703 14 TABLET in 1 BOTTLE (71335-0617-3) 14 tablet 2021-12-27 0000-00-00 No No Current 71335-0617-4 71335061704 60 TABLET in 1 BOTTLE (71335-0617-4) 60 tablet 2018-02-14 0000-00-00 No No Current 71335-0617-5 71335061705 90 TABLET in 1 BOTTLE (71335-0617-5) 90 tablet 2018-04-05 0000-00-00 No No Current 71335-0617-6 71335061706 6 TABLET in 1 BOTTLE (71335-0617-6) 6 tablet 2021-12-27 0000-00-00 No No Current 71335-0617-7 71335061707 120 TABLET in 1 BOTTLE (71335-0617-7) 120 tablet 2021-12-27 0000-00-00 No No Current