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United States · US · US:70512-814_419ad65e-5326-0755-e063-6394a90a7b2f

COXANTO

In shortageOrange BookUNIISPLATC M01AE12

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSOLA Pharmaceuticals, LLC
CountryUS (United States)
ATC codeM01AE12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051281460
    60 CAPSULE in 1 BOTTLE (70512-814-60)

Annotations

UNII (FDA Substance ID)
MHJ80W9LRB
OXAPROZIN
RxCUI 32613
Orange Book
N217927
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Oxaprozin Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "MHJ80W9LRB",
    "rxcui": "32613",
    "inchikey": "OFPXSFXSNFPTHF-UHFFFAOYSA-N",
    "display_name": "OXAPROZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "918127f0-9f2a-4edf-a2f7-07c01aa52bb5": {
      "match": "brand_token",
      "title": "COXANTO (OXAPROZIN) CAPSULE [SOLA PHARMACEUTICALS, LLC]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "70512-814_419ad65e-5326-0755-e063-6394a90a7b2f",
  "productndc": "70512-814",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217927",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Oct 20, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXAPROZIN",
  "shortage_reason": "Oxaprozin Tablet",
  "shortage_status": "current",
  "proprietary_name": "COXANTO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217927",
  "marketing_category": "NDA",
  "nonproprietary_name": "oxaprozin",
  "start_marketing_date": "20251103",
  "active_numerator_strength": "300"
}

Related drugs

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