dalbavancin hydrochloride

Generic: dalbavancin hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dalbavancin hydrochloride
Generic Name dalbavancin hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dalbavancin hydrochloride 500 mg/25mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-120
Product ID 65219-120_951cbf6d-768f-4a34-9ca9-fb87e2d30ab2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217591
Listing Expiration 2026-12-31
Marketing Start 2025-11-10

Pharmacologic Class

Classes
lipoglycopeptide antibacterial [epc] lipoglycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219120
Hyphenated Format 65219-120

Supplemental Identifiers

RxCUI
1539243
UPC
0365219120124
UNII
33WDQ7T81E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dalbavancin hydrochloride (source: ndc)
Generic Name dalbavancin hydrochloride (source: ndc)
Application Number ANDA217591 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/25mL
source: ndc
Packaging
  • 1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL
source: ndc

Packages (1)

65219-120-12 1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL

Ingredients (1)

dalbavancin hydrochloride (500 mg/25mL)

Linked Drug Pages (1)

DALBAVANCIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "951cbf6d-768f-4a34-9ca9-fb87e2d30ab2", "openfda": {"upc": ["0365219120124"], "unii": ["33WDQ7T81E"], "rxcui": ["1539243"], "spl_set_id": ["2c2ec45e-48a2-4887-8ab0-9244eb39a394"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 PACKAGE (65219-120-12)  / 25 mL in 1 VIAL", "package_ndc": "65219-120-12", "marketing_start_date": "20251110"}], "brand_name": "DALBAVANCIN HYDROCHLORIDE", "product_id": "65219-120_951cbf6d-768f-4a34-9ca9-fb87e2d30ab2", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Lipoglycopeptide Antibacterial [EPC]", "Lipoglycopeptides [CS]"], "product_ndc": "65219-120", "generic_name": "DALBAVANCIN HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DALBAVANCIN HYDROCHLORIDE", "active_ingredients": [{"name": "DALBAVANCIN HYDROCHLORIDE", "strength": "500 mg/25mL"}], "application_number": "ANDA217591", "marketing_category": "ANDA", "marketing_start_date": "20251110", "listing_expiration_date": "20261231"}