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United States · US · US:80425-0142_2a99a7f4-89e6-19db-e063-6294a90a90da

Celecoxib

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeM01AH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8042501421
    30 CAPSULE in 1 BOTTLE (80425-0142-1)
  • ndc11
    8042501422
    60 CAPSULE in 1 BOTTLE (80425-0142-2)

Annotations

UNII (FDA Substance ID)
JCX84Q7J1L
CELECOXIB
RxCUI 140587
Orange Book
A207446
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": "80425-0142_2a99a7f4-89e6-19db-e063-6294a90a90da",
  "productndc": "80425-0142",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207446",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Sep 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Sep 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Sep 23, 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": "ANDA207446",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Celecoxib",
  "start_marketing_date": "20170926",
  "active_numerator_strength": "100"
}

Related drugs

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