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United States · US · US:71335-2019_e8598d52-7e7b-4811-89ea-fa57e27c4d30

CELECOXIB

In shortageOrange BookUNIISPLATC M01AH01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM01AH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133520191
    30 CAPSULE in 1 BOTTLE (71335-2019-1)
  • ndc11
    7133520192
    20 CAPSULE in 1 BOTTLE (71335-2019-2)
  • ndc11
    7133520193
    60 CAPSULE in 1 BOTTLE (71335-2019-3)
  • ndc11
    7133520194
    90 CAPSULE in 1 BOTTLE (71335-2019-4)
  • ndc11
    7133520195
    120 CAPSULE in 1 BOTTLE (71335-2019-5)
  • ndc11
    7133520196
    14 CAPSULE in 1 BOTTLE (71335-2019-6)
  • ndc11
    7133520197
    10 CAPSULE in 1 BOTTLE (71335-2019-7)
  • ndc11
    7133520198
    28 CAPSULE in 1 BOTTLE (71335-2019-8)

Annotations

UNII (FDA Substance ID)
JCX84Q7J1L
CELECOXIB
RxCUI 140587
Orange Book
A210628
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": "71335-2019_e8598d52-7e7b-4811-89ea-fa57e27c4d30",
  "productndc": "71335-2019",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210628",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Nov 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Nov 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Nov 27, 2019"
      }
    ],
    "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": "ANDA210628",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CELECOXIB",
  "start_marketing_date": "20200903",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code M01AH01.

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