Clonidine

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378087299
4 POUCH in 1 CARTON (0378-0872-99) / 1 PATCH in 1 POUCH (0378-0872-16) / 7 d in 1 PATCH

Annotations

UNII (FDA Substance ID)

MN3L5RMN02

CLONIDINE

RxCUI 2599

Orange Book

A076166

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": "0378-0872_9979db75-b038-418e-b527-724d23c65932",
  "productndc": "0378-0872",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "076166",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG/24HR",
        "product_no": "001",
        "approval_date": "Jul 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2MG/24HR",
        "product_no": "002",
        "approval_date": "Jul 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3MG/24HR",
        "product_no": "003",
        "approval_date": "Jul 16, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE",
  "proprietary_name": "Clonidine",
  "active_ingred_unit": "mg/d",
  "application_number": "ANDA076166",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clonidine",
  "start_marketing_date": "20130304",
  "active_numerator_strength": ".2"
}

Related drugs

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