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United States · US · US:51662-1346_ef6d3bae-5393-440c-e053-2995a90a3a9f

CLONIDINE HCI

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeC02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5166213461
    1 VIAL, SINGLE-USE in 1 BOX (51662-1346-1) / 10 mL in 1 VIAL, SINGLE-USE

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": "51662-1346_ef6d3bae-5393-440c-e053-2995a90a3a9f",
  "productndc": "51662-1346",
  "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 HCI",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA200300",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CLONIDINE HCI",
  "start_marketing_date": "20181223",
  "active_numerator_strength": "100"
}

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