CELECOXIB

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6909742002
30 CAPSULE in 1 BOTTLE (69097-420-02)
ndc11
6909742003
60 CAPSULE in 1 BOTTLE (69097-420-03)
ndc11
6909742011
480 CAPSULE in 1 BOTTLE (69097-420-11)
ndc11
6909742021
10 BLISTER PACK in 1 CARTON (69097-420-21) / 10 CAPSULE in 1 BLISTER PACK (69097-420-19)

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": "69097-420_8df39b9c-af70-4ac3-ba9f-6e8e795ba961",
  "productndc": "69097-420",
  "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": "20150923",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code M01AH01.

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