🇺🇸
United States · US · US:71288-034_eb1f6798-3443-4fa7-95fc-fe4a387de46d
Dalbavancin
Orange BookUNIISPLATC J01XA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc
CountryUS (United States)
ATC codeJ01XA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288034501 VIAL, SINGLE-DOSE in 1 CARTON (71288-034-50) / 25 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
33WDQ7T81E
DALBAVANCIN HYDROCHLORIDE
RxCUI 1541465
Orange Book
A218929
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": "71288-034_eb1f6798-3443-4fa7-95fc-fe4a387de46d",
"productndc": "71288-034",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "218929",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 26, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DALBAVANCIN HYDROCHLORIDE",
"proprietary_name": "Dalbavancin",
"active_ingred_unit": "mg/25mL",
"application_number": "ANDA218929",
"marketing_category": "ANDA",
"nonproprietary_name": "Dalbavancin",
"start_marketing_date": "20251126",
"active_numerator_strength": "500"
}Related drugs
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