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United States · US · US:71335-2703_1327bc34-48ec-47da-879a-a3e7ebd369a3

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 · 8

  • ndc11
    7133527031
    30 CAPSULE in 1 BOTTLE (71335-2703-1)
  • ndc11
    7133527032
    10 CAPSULE in 1 BOTTLE (71335-2703-2)
  • ndc11
    7133527033
    8 CAPSULE in 1 BOTTLE (71335-2703-3)
  • ndc11
    7133527034
    90 CAPSULE in 1 BOTTLE (71335-2703-4)
  • ndc11
    7133527035
    60 CAPSULE in 1 BOTTLE (71335-2703-5)
  • ndc11
    7133527036
    3 CAPSULE in 1 BOTTLE (71335-2703-6)
  • ndc11
    7133527037
    20 CAPSULE in 1 BOTTLE (71335-2703-7)
  • ndc11
    7133527038
    6 CAPSULE in 1 BOTTLE (71335-2703-8)

Annotations

UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A215463
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": "71335-2703_1327bc34-48ec-47da-879a-a3e7ebd369a3",
  "productndc": "71335-2703",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215463",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.6MG",
        "product_no": "001",
        "approval_date": "Apr 29, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLCHICINE",
  "proprietary_name": "Colchicine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215463",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colchicine",
  "start_marketing_date": "20240429",
  "active_numerator_strength": ".6"
}

Related drugs

Other records sharing ATC code M04AC01.

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