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United States · US · US:67457-218_671a0224-c38b-4f2e-a132-fa38aa1a0797

Duraclon

Orange BookUNIIATC C02AC01

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

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeC02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6745721810
    1 VIAL in 1 CARTON (67457-218-10) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
W76I6XXF06
CLONIDINE HYDROCHLORIDE
RxCUI 142432
Orange Book
N020615
AP
Raw payload (JSON)
{
  "unii": {
    "unii": "W76I6XXF06",
    "rxcui": "142432",
    "inchikey": "ZNIFSRGNXRYGHF-UHFFFAOYSA-N",
    "display_name": "CLONIDINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "EPIDURAL",
  "productid": "67457-218_671a0224-c38b-4f2e-a132-fa38aa1a0797",
  "productndc": "67457-218",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020615",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/10ML (0.1MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 2, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Apr 27, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE HYDROCHLORIDE",
  "proprietary_name": "Duraclon",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020615",
  "marketing_category": "NDA",
  "nonproprietary_name": "clonidine hydrochloride",
  "start_marketing_date": "19970126",
  "active_numerator_strength": ".1"
}

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