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United States · US · US:60687-358_352e69e1-762b-4e39-e063-6294a90ac4f9

Colchicine

Orange BookUNIISPLATC M04AC01

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeM04AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068735825
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-358-25) / 1 CAPSULE in 1 BLISTER PACK (60687-358-95)

Annotations

UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N204820
AB
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": {
    "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": "60687-358_352e69e1-762b-4e39-e063-6294a90ac4f9",
  "productndc": "60687-358",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204820",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.6MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICINE",
  "proprietary_name": "Colchicine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204820",
  "marketing_category": "NDA",
  "nonproprietary_name": "Colchicine",
  "start_marketing_date": "20180404",
  "active_numerator_strength": ".6"
}

Related drugs

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