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United States · US · US:82867-001_247fc59c-53cc-90da-e063-6394a90aac8d

LODOCO

Orange BookUNIISPLATC M04AC01

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

Identification

ManufacturerAGEPHA Pharma USA, LLC
CountryUS (United States)
ATC codeM04AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8286700101
    1 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACK
  • ndc11
    8286700102
    1 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N215727
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": {
    "ff06d68f-d65f-d097-e053-6294a90a7e5f": {
      "match": "brand_token",
      "title": "LODOCO (COLCHICINE TABLETS 0.5 MG) TABLET [AGEPHA PHARMA USA, LLC]",
      "spl_version": "3",
      "published_date": "2026-01-14"
    }
  },
  "productid": "82867-001_247fc59c-53cc-90da-e063-6394a90aac8d",
  "productndc": "82867-001",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215727",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Jun 16, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICINE",
  "proprietary_name": "LODOCO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215727",
  "marketing_category": "NDA",
  "nonproprietary_name": "Colchicine Tablets 0.5 mg",
  "start_marketing_date": "20230616",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code M04AC01.

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