CELECOXIB

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4306366910
10 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-10)
ndc11
4306366914
14 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-14)
ndc11
4306366920
20 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-20)
ndc11
4306366930
30 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-30)
ndc11
4306366960
60 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-60)

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": "43063-669_3284fb4d-544b-d0dc-e063-6394a90a8af4",
  "productndc": "43063-669",
  "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": "200"
}

Related drugs

Other records sharing ATC code M01AH01.

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