Celecoxib

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeM01AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4670826812
80 CAPSULE in 1 CARTON (46708-268-12)
ndc11
4670826830
30 CAPSULE in 1 BOTTLE (46708-268-30)
ndc11
4670826831
100 CAPSULE in 1 BOTTLE (46708-268-31)
ndc11
4670826860
60 CAPSULE in 1 BOTTLE (46708-268-60)
ndc11
4670826871
500 CAPSULE in 1 BOTTLE (46708-268-71)
ndc11
4670826891
1000 CAPSULE in 1 BOTTLE (46708-268-91)

Annotations

UNII (FDA Substance ID)

JCX84Q7J1L

CELECOXIB

RxCUI 140587

Orange Book

A204519

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": "46708-268_c884ffd4-3a40-48a1-99b6-73b1ef9324b4",
  "productndc": "46708-268",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204519",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 21, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Aug 21, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Aug 21, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Aug 21, 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": "ANDA204519",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Celecoxib",
  "start_marketing_date": "20150822",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code M01AH01.

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