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United States · US · US:63187-292_db4b884e-dd04-4097-83fe-a42f171bf9a5

Colcrys

Orange BookUNIIATC M04AC01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM04AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6318729203
    3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-292-03)

Annotations

UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N022352
Raw payload (JSON)
{
  "unii": {
    "unii": "SML2Y3J35T",
    "rxcui": "2683",
    "inchikey": "IAKHMKGGTNLKSZ-INIZCTEOSA-N",
    "display_name": "COLCHICINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "63187-292_db4b884e-dd04-4097-83fe-a42f171bf9a5",
  "productndc": "63187-292",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022352",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jul 29, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICINE",
  "proprietary_name": "Colcrys",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022352",
  "marketing_category": "NDA",
  "nonproprietary_name": "Colchicine",
  "start_marketing_date": "20090901",
  "active_numerator_strength": ".6"
}

Related drugs

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