🇺🇸
United States · US · US:65219-120_e9e7ab64-7f96-41c4-abb4-f71b77e60245
DALBAVANCIN HYDROCHLORIDE
Orange BookUNIISPLATC J01XA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01XA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165219120121 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
33WDQ7T81E
DALBAVANCIN HYDROCHLORIDE
RxCUI 1541465
Orange Book
A217591
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "33WDQ7T81E",
"rxcui": "1541465",
"inchikey": null,
"display_name": "DALBAVANCIN HYDROCHLORIDE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"2c2ec45e-48a2-4887-8ab0-9244eb39a394": {
"match": "brand_token",
"title": "DALBAVANCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "2",
"published_date": "2026-04-16"
}
},
"productid": "65219-120_e9e7ab64-7f96-41c4-abb4-f71b77e60245",
"productndc": "65219-120",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "217591",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 10, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DALBAVANCIN HYDROCHLORIDE",
"proprietary_name": "DALBAVANCIN HYDROCHLORIDE",
"active_ingred_unit": "mg/25mL",
"application_number": "ANDA217591",
"marketing_category": "ANDA",
"nonproprietary_name": "DALBAVANCIN HYDROCHLORIDE",
"start_marketing_date": "20251110",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01XA04.
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- DKDalbavancin "Adalvo"AdAlvo Limited
- DKDalbavancin "Baxter"Baxter Holding B.V.
- DKDalbavancin "Teva"Teva B.V.
- DKDalbavancin "Tillomed"Tillomed Malta Limited
- GBDalbavancin 500mg powder for concentrate for solution for infusion vialsAccord-UK Ltd
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