Clonidine

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3982220101
10 mL in 1 VIAL, SINGLE-DOSE (39822-2010-1)

Annotations

UNII (FDA Substance ID)

W76I6XXF06

CLONIDINE HYDROCHLORIDE

RxCUI 142432

Orange Book

A203167

APAP

DailyMed SPL labels

1 version tracked

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",
  "spl_meta": {
    "ea1527a5-4939-4ff7-a827-f88a9113a07d": {
      "match": "brand_token",
      "title": "CLONIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "15",
      "published_date": "2026-05-28"
    }
  },
  "productid": "39822-2010_103027a7-2f0d-8d8c-e063-6294a90aedc7",
  "productndc": "39822-2010",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203167",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/10ML (0.1MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 29, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/10ML (0.5MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 29, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE HYDROCHLORIDE",
  "proprietary_name": "Clonidine",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA203167",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonidine",
  "start_marketing_date": "20131029",
  "active_numerator_strength": "500"
}

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