Clonidine transdermal system

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0591350804
4 POUCH in 1 CARTON (0591-3508-04) / 1 PATCH in 1 POUCH (0591-3508-54) / 7 d in 1 PATCH

Annotations

UNII (FDA Substance ID)

MN3L5RMN02

CLONIDINE

RxCUI 2599

Orange Book

A090873

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "MN3L5RMN02",
    "rxcui": "2599",
    "inchikey": "GJSURZIOUXUGAL-UHFFFAOYSA-N",
    "display_name": "CLONIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "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": "0591-3508_996f475b-4f8b-4487-b5c1-6e5c4f284045",
  "productndc": "0591-3508",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "090873",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG/24HR",
        "product_no": "001",
        "approval_date": "May 6, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2MG/24HR",
        "product_no": "002",
        "approval_date": "May 6, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3MG/24HR",
        "product_no": "003",
        "approval_date": "May 6, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE",
  "proprietary_name": "Clonidine transdermal system",
  "active_ingred_unit": "mg/d",
  "application_number": "ANDA090873",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonidine",
  "start_marketing_date": "20140506",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code C02AC01.

Access this data programmatically

Query Clonidine transdermal system 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