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United States · US · US:15370-501_28480106-933c-452e-acfd-75e1fe7179e4

VYSCOXA

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerCarwin Pharmaceutical Associates, LLC
CountryUS (United States)
ATC codeM01AH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1537050116
    473 mL in 1 BOTTLE (15370-501-16)

Annotations

UNII (FDA Substance ID)
JCX84Q7J1L
CELECOXIB
RxCUI 140587
Orange Book
N211759
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Celecoxib Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "JCX84Q7J1L",
    "rxcui": "140587",
    "inchikey": "RZEKVGVHFLEQIL-UHFFFAOYSA-N",
    "display_name": "CELECOXIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5094d47e-f791-4190-9397-b7500143a74d": {
      "match": "brand_token",
      "title": "VYSCOXA (CELECOXIB) SUSPENSION [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]",
      "spl_version": "1",
      "published_date": "2025-08-14"
    }
  },
  "productid": "15370-501_28480106-933c-452e-acfd-75e1fe7179e4",
  "productndc": "15370-501",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "211759",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jul 29, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CELECOXIB",
  "shortage_reason": "Celecoxib Capsule",
  "shortage_status": "current",
  "proprietary_name": "VYSCOXA",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA211759",
  "marketing_category": "NDA",
  "nonproprietary_name": "Celecoxib",
  "start_marketing_date": "20250731",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AH01.

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