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United States · US · US:16714-039_b510d002-4c8e-4b5e-bc76-c49552e79d45

Colchicine

Orange BookUNIISPL

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

Identification

ManufacturerNorthstar Rx LLC.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1671403901
    1 BOTTLE in 1 CARTON (16714-039-01) / 30 TABLET in 1 BOTTLE
  • ndc11
    1671403902
    1 BOTTLE in 1 CARTON (16714-039-02) / 100 TABLET in 1 BOTTLE

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": "16714-039_b510d002-4c8e-4b5e-bc76-c49552e79d45",
  "productndc": "16714-039",
  "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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