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United States · US · US:13668-442_bff3a32b-43e3-46cd-b5c3-b691617fe4fa

celecoxib

In shortageOrange BookUNIISPLATC M01AH01

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

Identification

ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeM01AH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    1366844201
    100 CAPSULE in 1 BOTTLE (13668-442-01)
  • ndc11
    1366844205
    500 CAPSULE in 1 BOTTLE (13668-442-05)
  • ndc11
    1366844210
    1000 CAPSULE in 1 BOTTLE (13668-442-10)
  • ndc11
    1366844230
    30 CAPSULE in 1 BOTTLE (13668-442-30)
  • ndc11
    1366844260
    60 CAPSULE in 1 BOTTLE (13668-442-60)
  • ndc11
    1366844290
    90 CAPSULE in 1 BOTTLE (13668-442-90)

Annotations

UNII (FDA Substance ID)
JCX84Q7J1L
CELECOXIB
RxCUI 140587
Orange Book
A207677
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": "13668-442_bff3a32b-43e3-46cd-b5c3-b691617fe4fa",
  "productndc": "13668-442",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207677",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Dec 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Dec 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Dec 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Dec 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": "ANDA207677",
  "marketing_category": "ANDA",
  "nonproprietary_name": "celecoxib",
  "start_marketing_date": "20151223",
  "active_numerator_strength": "200"
}

Related drugs

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