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United States · US · US:24478-148_00de799f-c9cb-42b7-8471-5bde35108200

ONYDA XR

Orange BookUNIISPLATC C02AC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNextWave Pharmaceuticals, Inc
CountryUS (United States)
ATC codeC02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2447814801
    7 mL in 1 BOTTLE (24478-148-01)
  • ndc11
    2447814803
    30 mL in 1 BOTTLE (24478-148-03)

Annotations

UNII (FDA Substance ID)
W76I6XXF06
CLONIDINE HYDROCHLORIDE
RxCUI 142432
Orange Book
N217645
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": {
    "4a15c850-9da5-4bdc-a34d-7f740a6149b7": {
      "match": "brand_token",
      "title": "ONYDA XR (CLONIDINE HYDROCHLORIDE) SUSPENSION, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]",
      "spl_version": "14",
      "published_date": "2025-05-01"
    }
  },
  "productid": "24478-148_00de799f-c9cb-42b7-8471-5bde35108200",
  "productndc": "24478-148",
  "dosage_form": "SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217645",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1MG/ML",
        "product_no": "001",
        "approval_date": "May 24, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE HYDROCHLORIDE",
  "proprietary_name": "ONYDA XR",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA217645",
  "marketing_category": "NDA",
  "nonproprietary_name": "Clonidine hydrochloride",
  "start_marketing_date": "20240813",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code C02AC01.

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