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United States · US · US:50090-5638_0d540a4e-27a4-4acc-b51c-5e6f9873dded

celecoxib

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeM01AH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5009056380
    30 CAPSULE in 1 BOTTLE (50090-5638-0)
  • ndc11
    5009056381
    60 CAPSULE in 1 BOTTLE (50090-5638-1)
  • ndc11
    5009056382
    90 CAPSULE in 1 BOTTLE (50090-5638-2)

Annotations

UNII (FDA Substance ID)
JCX84Q7J1L
CELECOXIB
RxCUI 140587
Orange Book
A202240
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": {
    "27f17ae7-939b-402e-9498-3b6611104089": {
      "match": "brand_token",
      "title": "CELECOXIB CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "7",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50090-5638_0d540a4e-27a4-4acc-b51c-5e6f9873dded",
  "productndc": "50090-5638",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "202240",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jun 9, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Jun 9, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Jun 9, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CELECOXIB",
  "shortage_reason": "Celecoxib Capsule",
  "shortage_status": "current",
  "proprietary_name": "celecoxib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202240",
  "marketing_category": "ANDA",
  "nonproprietary_name": "celecoxib",
  "start_marketing_date": "20191209",
  "active_numerator_strength": "200"
}

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