Clonidine hydrochloride

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161044909
9000 TABLET in 1 BOTTLE (71610-449-09)

Annotations

UNII (FDA Substance ID)

W76I6XXF06

CLONIDINE HYDROCHLORIDE

RxCUI 142432

Orange Book

A070923

ABABAB

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": "ORAL",
  "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": "71610-449_6e5cec35-31fa-4db7-a681-cd264ebd6cbf",
  "productndc": "71610-449",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070923",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3MG",
        "product_no": "001",
        "approval_date": "Sep 4, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2MG",
        "product_no": "002",
        "approval_date": "Sep 4, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG",
        "product_no": "003",
        "approval_date": "Sep 4, 1987"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.05MG",
        "product_no": "004",
        "approval_date": "Apr 6, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE HYDROCHLORIDE",
  "proprietary_name": "Clonidine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070923",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonidine hydrochloride",
  "start_marketing_date": "20170601",
  "active_numerator_strength": ".3"
}

Related drugs

Other records sharing ATC code C02AC01.

Access this data programmatically

Query Clonidine hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs