Home NDC 70512-787 Oxaprozin
Product NDC 70512-787
11-digit product format 705120787
Labeler code 70512
Product ID 70512-787_450f5941-7f11-42fe-e063-6394a90a4803
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxaprozin
Dosage form CAPSULE
Route ORAL
Labeler SOLA Pharmaceuticals, LLC
Application NDA217927
Marketing category NDA
Marketing start 2025-12-03
Substance OXAPROZIN
Active strength 300 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 N217927-001 COXANTO OXAPROZIN 300MG CAPSULE / ORAL RLD, RS 2023-10-20
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.
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 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217927-001 COXANTO 300MG CAPSULE / ORAL RLD, RS 2023-10-20 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Oxaprozin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXAPROZIN 300 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 2668162 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 70512-787-60 Oxaprozin 60 in 1 BOTTLE CAPSULE 60 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70512-787-60 70512078760 60 CAPSULE in 1 BOTTLE (70512-787-60) 60 capsule 2025-12-03 No No Current