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United States · US · US:30698-455_490e0fcd-3542-c976-e063-6294a90ac2ce
RALDESY
Orange BookUNIISPLATC N06AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerValidus Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc113069845501300 mL in 1 BOTTLE (30698-455-01)
- ndc113069845502150 mL in 1 BOTTLE (30698-455-02)
- ndc113069845503150 mL in 1 BOTTLE, GLASS (30698-455-03)
- ndc113069845504300 mL in 1 BOTTLE, GLASS (30698-455-04)
Annotations
UNII (FDA Substance ID)
6E8ZO8LRNM
TRAZODONE HYDROCHLORIDE
RxCUI 82112
Orange Book
N218637
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6E8ZO8LRNM",
"rxcui": "82112",
"inchikey": "OHHDIOKRWWOXMT-UHFFFAOYSA-N",
"display_name": "TRAZODONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"34708cc1-b0b2-4fd0-b9f3-7f008b457fc9": {
"match": "brand_token",
"title": "RALDESY TM (TRAZODONE HYDROCHLORIDE ORAL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]",
"spl_version": "4",
"published_date": "2026-01-26"
}
},
"productid": "30698-455_490e0fcd-3542-c976-e063-6294a90ac2ce",
"productndc": "30698-455",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "218637",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Nov 26, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRAZODONE HYDROCHLORIDE",
"proprietary_name": "RALDESY",
"active_ingred_unit": "mg/mL",
"application_number": "NDA218637",
"marketing_category": "NDA",
"nonproprietary_name": "TRAZODONE HYDROCHLORIDE ORAL",
"start_marketing_date": "20241126",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AX05.
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