ELYXYB - celecoxib

In shortageOrange BookUNIISPLATC M01AH01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSCILEX PHARMACEUTICALS INC.

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6955733301
6 BOTTLE in 1 CARTON (69557-333-01) / 4.8 mL in 1 BOTTLE
ndc11
6955733302
1 BOTTLE in 1 CARTON (69557-333-02) / 4.8 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

JCX84Q7J1L

CELECOXIB

RxCUI 140587

Orange Book

N212157

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": {
    "c8a5de07-9f27-4a54-a885-8089f0307bd7": {
      "match": "brand_token",
      "title": "ELYXYB - CELECOXIB (CELECOXIB) LIQUID [SCILEX PHARMACEUTICALS INC.]",
      "spl_version": "3",
      "published_date": "2024-12-06"
    }
  },
  "productid": "69557-333_ad5c6af3-1790-4a13-b4e5-6e3af543b2a8",
  "productndc": "69557-333",
  "dosage_form": "LIQUID",
  "orange_book": {
    "appl_no": "212157",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "May 5, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CELECOXIB",
  "shortage_reason": "Celecoxib Capsule",
  "shortage_status": "current",
  "proprietary_name": "ELYXYB - celecoxib",
  "active_ingred_unit": "mg/4.8mL",
  "application_number": "NDA212157",
  "marketing_category": "NDA",
  "nonproprietary_name": "celecoxib",
  "start_marketing_date": "20231127",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code M01AH01.

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