CELEBREX

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5815108401
100 CAPSULE in 1 BOTTLE (58151-084-01)
ndc11
5815108405
500 CAPSULE in 1 BOTTLE (58151-084-05)
ndc11
5815108488
100 BLISTER PACK in 1 CARTON (58151-084-88) / 1 CAPSULE in 1 BLISTER PACK (58151-084-32)

Annotations

UNII (FDA Substance ID)

JCX84Q7J1L

CELECOXIB

RxCUI 140587

Orange Book

N020998

ABABABAB

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": {
    "2d6675e4-5859-4be2-8037-a20ce9f707aa": {
      "match": "brand_token",
      "title": "CELEBREX (CELECOXIB) CAPSULE [VIATRIS SPECIALTY LLC]",
      "spl_version": "13",
      "published_date": "2025-12-18"
    }
  },
  "productid": "58151-084_0c321a7b-89e4-48cc-ab0b-1bd7620d7799",
  "productndc": "58151-084",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "020998",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 31, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 31, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Aug 29, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Dec 15, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CELECOXIB",
  "shortage_reason": "Celecoxib Capsule",
  "shortage_status": "current",
  "proprietary_name": "CELEBREX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020998",
  "marketing_category": "NDA",
  "nonproprietary_name": "Celecoxib",
  "start_marketing_date": "20240110",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code M01AH01.

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