Clonidine

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerPALMETTO PHARMACEUTICALS INC.

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6813460330
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68134-603-30)

Annotations

UNII (FDA Substance ID)

MN3L5RMN02

CLONIDINE

RxCUI 2599

Orange Book

N022500

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": "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": "68134-603_0eb6eb87-c779-3b79-e063-6294a90a5944",
  "productndc": "68134-603",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022500",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.17MG BASE",
        "product_no": "001",
        "approval_date": "Dec 3, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.26MG BASE",
        "product_no": "002",
        "approval_date": "Dec 3, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE",
  "proprietary_name": "Clonidine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022500",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Clonidine",
  "start_marketing_date": "20220301",
  "active_numerator_strength": ".17"
}

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