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United States · US · US:0591-5325_08577252-5289-46f0-80b4-06442a22b332

Probenecid and Colchicine

Orange BookUNIISPLATC M04AC

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeM04AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591532501
    100 TABLET in 1 BOTTLE, PLASTIC (0591-5325-01)

Annotations

UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A084279
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SML2Y3J35T",
    "rxcui": "2683",
    "inchikey": "IAKHMKGGTNLKSZ-INIZCTEOSA-N",
    "display_name": "COLCHICINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "65b4888c-d49a-433f-9bfd-17880ae40069": {
      "match": "brand_token",
      "title": "PROBENECID TABLET [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0591-5325_08577252-5289-46f0-80b4-06442a22b332",
  "productndc": "0591-5325",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "084279",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG;500MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICINE; PROBENECID",
  "proprietary_name": "Probenecid and Colchicine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA084279",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Probenecid and Colchicine",
  "start_marketing_date": "19821001",
  "active_numerator_strength": ".5; 500"
}

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