CELECOXIB

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerNorthwind Health Company, LLC

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5165543725
60 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-25)
ndc11
5165543726
90 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-26)
ndc11
5165543752
30 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-52)
ndc11
5165543784
14 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-84)

Annotations

UNII (FDA Substance ID)

JCX84Q7J1L

CELECOXIB

RxCUI 140587

Orange Book

A204776

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": "51655-437_4b43d8e7-a5d3-238d-e063-6294a90a33dc",
  "productndc": "51655-437",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204776",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Apr 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Apr 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Apr 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Apr 30, 2018"
      }
    ],
    "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": "ANDA204776",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Celecoxib",
  "start_marketing_date": "20200928",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code M01AH01.

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