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United States · US · US:70771-1590_9bfd545b-8ea3-4758-b6dc-fff2e9af14ee

Colchicine

Orange BookUNIISPL

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7077115901
    1 BOTTLE in 1 CARTON (70771-1590-1) / 100 TABLET in 1 BOTTLE
  • ndc11
    7077115903
    1 BOTTLE in 1 CARTON (70771-1590-3) / 30 TABLET in 1 BOTTLE
  • ndc11
    7077115905
    1 BOTTLE in 1 CARTON (70771-1590-5) / 500 TABLET in 1 BOTTLE
  • ndc11
    7077115909
    1 BOTTLE in 1 CARTON (70771-1590-9) / 90 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": "70771-1590_9bfd545b-8ea3-4758-b6dc-fff2e9af14ee",
  "productndc": "70771-1590",
  "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": "20210510",
  "active_numerator_strength": ".3"
}

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