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United States · US · US:50090-7205_6fa1e18b-babc-4a4b-af7c-144980645666

Colchicine

Orange BookUNIISPL

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009072057
    4 TABLET in 1 BOTTLE (50090-7205-7)

Annotations

UNII (FDA Substance ID)
HJ30158L57
COLCHICEINE
RxCUI 2174385
Orange Book
A211519
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "HJ30158L57",
    "rxcui": "2174385",
    "inchikey": "PRGILOMAMBLWNG-HNNXBMFYSA-N",
    "display_name": "COLCHICEINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "68d4bf2b-8e2c-4621-aa08-463f43e253c3": {
      "match": "brand_token",
      "title": "COLCHICINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-05-22"
    }
  },
  "productid": "50090-7205_6fa1e18b-babc-4a4b-af7c-144980645666",
  "productndc": "50090-7205",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211519",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.6MG",
        "product_no": "001",
        "approval_date": "Feb 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.3MG",
        "product_no": "002",
        "approval_date": "Nov 14, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICEINE",
  "proprietary_name": "Colchicine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211519",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colchicine",
  "start_marketing_date": "20201110",
  "active_numerator_strength": ".6"
}

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