colchicine

Orange BookUNIISPLATC M04AC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeM04AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6787758910
1000 TABLET in 1 BOTTLE (67877-589-10)
ndc11
6787758901
100 TABLET in 1 BOTTLE (67877-589-01)
ndc11
6787758905
500 TABLET in 1 BOTTLE (67877-589-05)
ndc11
6787758930
30 TABLET in 1 BOTTLE (67877-589-30)
ndc11
6787758933
1 BLISTER PACK in 1 CARTON (67877-589-33) / 10 TABLET in 1 BLISTER PACK
ndc11
6787758960
60 TABLET in 1 BOTTLE (67877-589-60)
ndc11
6787758984
3 BLISTER PACK in 1 CARTON (67877-589-84) / 10 TABLET in 1 BLISTER PACK
ndc11
6787758986
250 TABLET in 1 BOTTLE (67877-589-86)

Annotations

UNII (FDA Substance ID)

SML2Y3J35T

COLCHICINE

RxCUI 2683

Orange Book

A211250

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": "67877-589_498d5cac-62d7-4f25-b974-52b732abd789",
  "productndc": "67877-589",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211250",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.6MG",
        "product_no": "001",
        "approval_date": "Feb 8, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICINE",
  "proprietary_name": "colchicine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211250",
  "marketing_category": "ANDA",
  "nonproprietary_name": "colchicine",
  "start_marketing_date": "20190210",
  "active_numerator_strength": ".6"
}

Related drugs

Other records sharing ATC code M04AC01.

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