🇺🇸
United States · US · US:81298-2390_3b4d8110-d32a-4c82-9a43-8d3516dd4b1a
Dalbavancin
Orange BookUNIISPLATC J01XA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLong Grove Pharmaceuticals, LLC
CountryUS (United States)
ATC codeJ01XA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1181298239011 VIAL in 1 CARTON (81298-2390-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
33WDQ7T81E
DALBAVANCIN HYDROCHLORIDE
RxCUI 1541465
Orange Book
A218602
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": "81298-2390_3b4d8110-d32a-4c82-9a43-8d3516dd4b1a",
"productndc": "81298-2390",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "218602",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Feb 26, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DALBAVANCIN HYDROCHLORIDE",
"proprietary_name": "Dalbavancin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218602",
"marketing_category": "ANDA",
"nonproprietary_name": "dalbavancin hydrochloride",
"start_marketing_date": "20260303",
"active_numerator_strength": "500"
}Related drugs
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