Home NDC 70512-814 COXANTO
Product NDC 70512-814
11-digit product format 705120814
Labeler code 70512
Product ID 70512-814_419ad65e-5326-0755-e063-6394a90a7b2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxaprozin
Dosage form CAPSULE
Route ORAL
Labeler SOLA Pharmaceuticals, LLC
Application NDA217927
Marketing category NDA
Marketing start 2025-11-03
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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base COXANTO
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2668162 Internal RxNorm lookup 2668168 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 70512-814-60 COXANTO 60 in 1 BOTTLE CAPSULE 60 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70512-814-60 70512081460 60 CAPSULE in 1 BOTTLE (70512-814-60) 60 capsule 2025-11-03 No No Current