Celecoxib

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7642084501
1 CAPSULE in 1 BOTTLE (76420-845-01)
ndc11
7642084505
500 CAPSULE in 1 BOTTLE (76420-845-05)
ndc11
7642084507
7 CAPSULE in 1 BOTTLE (76420-845-07)
ndc11
7642084514
14 CAPSULE in 1 BOTTLE (76420-845-14)
ndc11
7642084520
20 CAPSULE in 1 BOTTLE (76420-845-20)
ndc11
7642084530
30 CAPSULE in 1 BOTTLE (76420-845-30)
ndc11
7642084560
60 CAPSULE in 1 BOTTLE (76420-845-60)
ndc11
7642084590
90 CAPSULE in 1 BOTTLE (76420-845-90)

Annotations

UNII (FDA Substance ID)

JCX84Q7J1L

CELECOXIB

RxCUI 140587

Orange Book

A205129

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": "76420-845_327a5fba-3c08-7bba-e063-6294a90a75e5",
  "productndc": "76420-845",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205129",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Dec 3, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Dec 3, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Dec 3, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Dec 3, 2020"
      }
    ],
    "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": "ANDA205129",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Celecoxib",
  "start_marketing_date": "20201203",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code M01AH01.

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