Clonidine Hydrochloride

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143972301
10 mL in 1 VIAL, SINGLE-USE (0143-9723-01)

Annotations

UNII (FDA Substance ID)

W76I6XXF06

CLONIDINE HYDROCHLORIDE

RxCUI 142432

Orange Book

A200300

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": "INTRAVENOUS",
  "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": "0143-9723_9d6244d1-5e85-4da3-b06c-f4fe8da1b6fa",
  "productndc": "0143-9723",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "200300",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/10ML (0.1MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 26, 2011"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/10ML (0.5MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 26, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE HYDROCHLORIDE",
  "proprietary_name": "Clonidine Hydrochloride",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA200300",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonidine Hydrochloride",
  "start_marketing_date": "20110101",
  "active_numerator_strength": "500"
}

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