JAVADIN

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2433811501
1 BOTTLE in 1 CARTON (24338-115-01) / 250 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

W76I6XXF06

CLONIDINE HYDROCHLORIDE

RxCUI 142432

Orange Book

N220256

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": {
    "c36d94f5-a30d-4997-b141-e79a4ea45ecf": {
      "match": "brand_token",
      "title": "JAVADIN (CLONIDINE HYDROCHLORIDE ORAL) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2025-11-17"
    }
  },
  "productid": "24338-115_c36d94f5-a30d-4997-b141-e79a4ea45ecf",
  "productndc": "24338-115",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "220256",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02MG/ML",
        "product_no": "001",
        "approval_date": "Oct 23, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE HYDROCHLORIDE",
  "proprietary_name": "JAVADIN",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA220256",
  "marketing_category": "NDA",
  "nonproprietary_name": "clonidine hydrochloride oral",
  "start_marketing_date": "20251023",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C02AC01.

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