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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
- ndc1124478148017 mL in 1 BOTTLE (24478-148-01)
- ndc11244781480330 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
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