celecoxib

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
8576603000
100 CAPSULE in 1 BOTTLE (85766-030-00)
ndc11
8576603001
1 CAPSULE in 1 BOTTLE (85766-030-01)
ndc11
8576603007
7 CAPSULE in 1 BOTTLE (85766-030-07)
ndc11
8576603010
10 CAPSULE in 1 BOTTLE (85766-030-10)
ndc11
8576603014
14 CAPSULE in 1 BOTTLE (85766-030-14)
ndc11
8576603020
20 CAPSULE in 1 BOTTLE (85766-030-20)
ndc11
8576603030
30 CAPSULE in 1 BOTTLE (85766-030-30)
ndc11
8576603060
60 CAPSULE in 1 BOTTLE (85766-030-60)
ndc11
8576603090
90 CAPSULE in 1 BOTTLE (85766-030-90)

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": "85766-030_4a16aad9-d46e-bf19-e063-6394a90a0326",
  "productndc": "85766-030",
  "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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