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United States · US · US:71335-2791_e4d9651d-0570-418b-8a5e-c3d2b99bb3c5

Colchicine

Orange BookUNIISPLATC M04AC01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM04AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133527911
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2791-1)
  • ndc11
    7133527912
    20 TABLET, FILM COATED in 1 BOTTLE (71335-2791-2)
  • ndc11
    7133527913
    3 TABLET, FILM COATED in 1 BOTTLE (71335-2791-3)
  • ndc11
    7133527914
    12 TABLET, FILM COATED in 1 BOTTLE (71335-2791-4)
  • ndc11
    7133527915
    6 TABLET, FILM COATED in 1 BOTTLE (71335-2791-5)
  • ndc11
    7133527916
    9 TABLET, FILM COATED in 1 BOTTLE (71335-2791-6)
  • ndc11
    7133527917
    15 TABLET, FILM COATED in 1 BOTTLE (71335-2791-7)
  • ndc11
    7133527918
    10 TABLET, FILM COATED in 1 BOTTLE (71335-2791-8)
  • ndc11
    7133527919
    90 TABLET, FILM COATED in 1 BOTTLE (71335-2791-9)

Annotations

UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A208993
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": "71335-2791_e4d9651d-0570-418b-8a5e-c3d2b99bb3c5",
  "productndc": "71335-2791",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208993",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.6MG",
        "product_no": "001",
        "approval_date": "Aug 13, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICINE",
  "proprietary_name": "Colchicine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208993",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colchicine",
  "start_marketing_date": "20210813",
  "active_numerator_strength": ".6"
}

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