Clonidine Transdermal System USP, 0.3 mg/day

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerTruPharma, LLC

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5281761204
4 POUCH in 1 CARTON (52817-612-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH

Annotations

UNII (FDA Substance ID)

MN3L5RMN02

CLONIDINE

RxCUI 2599

Orange Book

N018891

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": "52817-612_304ded76-8279-4755-84e9-ad226ba034e8",
  "productndc": "52817-612",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "018891",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1MG/24HR",
        "product_no": "001",
        "approval_date": "Oct 10, 1984"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.2MG/24HR",
        "product_no": "002",
        "approval_date": "Oct 10, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.3MG/24HR",
        "product_no": "003",
        "approval_date": "Oct 10, 1984"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE",
  "proprietary_name": "Clonidine Transdermal System USP, 0.3 mg/day",
  "active_ingred_unit": "mg/d",
  "application_number": "NDA018891",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "clonidine transdermal system",
  "start_marketing_date": "20230630",
  "active_numerator_strength": ".3"
}

Related drugs

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