celecoxib

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3334215809
60 CAPSULE in 1 BOTTLE (33342-158-09)
ndc11
3334215812
10 BLISTER PACK in 1 CARTON (33342-158-12) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

JCX84Q7J1L

CELECOXIB

RxCUI 140587

Orange Book

A204590

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": "33342-158_bab34b9b-3e23-475d-a538-c0e3fe08be49",
  "productndc": "33342-158",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204590",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Mar 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Mar 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Mar 16, 2016"
      }
    ],
    "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": "ANDA204590",
  "marketing_category": "ANDA",
  "nonproprietary_name": "celecoxib",
  "start_marketing_date": "20160316",
  "active_numerator_strength": "400"
}

Related drugs

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