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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217927-001COXANTOOXAPROZIN300MGCAPSULE / ORALRLD, RS2023-10-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-208072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217927-001COXANTO300MGCAPSULE / ORALRLD, RS2023-10-20a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxaprozinOXAPROZINSOLA Pharmaceuticals, LLC450f5941-7f10-42fe-e063-6394a90a48032025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217927
application number: NDA217927
COXANTOOXAPROZINSOLA Pharmaceuticals, LLC918127f0-9f2a-4edf-a2f7-07c01aa52bb52025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217927
application number: NDA217927
ndc (product): 70512-814

Additional Listing Data#

Finished product
Yes
Brand name base
COXANTO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXAPROZIN300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MHJ80W9LRBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2668162Internal RxNorm lookup
2668168Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
918127f0-9f2a-4edf-a2f7-07c01aa52bb5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95b4bbb5-24e2-44a4-b351-d64e35d6e76aProduct name120250722
486cfca4-efa2-1446-eef2-3c74b667bb18Product name220170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-814-60COXANTO60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-814-60EA - Each70512-814cb4cb14c-c894-49a5-8069-75b65a5c13db12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2668168COXANTO 300 MG Oral CapsulePSN918127f0-9f2a-4edf-a2f7-07c01aa52bb52
2668162oxaprozin 300 MG Oral CapsulePSN918127f0-9f2a-4edf-a2f7-07c01aa52bb52
2668168oxaprozin 300 MG Oral Capsule [Coxanto]SBD918127f0-9f2a-4edf-a2f7-07c01aa52bb52
2668162oxaprozin 300 MG Oral CapsuleSCD918127f0-9f2a-4edf-a2f7-07c01aa52bb52
2668168Coxanto 300 MG Oral CapsuleSY918127f0-9f2a-4edf-a2f7-07c01aa52bb52
2668162oxaprozin 300 MG Oral CapsuleSY918127f0-9f2a-4edf-a2f7-07c01aa52bb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70512-814-607051208146060 CAPSULE in 1 BOTTLE (70512-814-60) 60 capsule2025-11-03NoNoCurrent