dalbavancin

Generic: dalbavancin

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dalbavancin
Generic Name dalbavancin
Labeler teva pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dalbavancin hydrochloride 500 mg/25mL

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3325
Product ID 0480-3325_7fddacee-2401-4514-acf0-3847da11c6e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219465
Listing Expiration 2026-12-31
Marketing Start 2025-10-29

Pharmacologic Class

Classes
lipoglycopeptide antibacterial [epc] lipoglycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803325
Hyphenated Format 0480-3325

Supplemental Identifiers

RxCUI
1539243
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 (source: ndc)
Generic Name dalbavancin (source: ndc)
Application Number ANDA219465 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/25mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0480-3325-01) / 25 mL in 1 VIAL
source: ndc

Packages (1)

0480-3325-01 1 VIAL in 1 CARTON (0480-3325-01) / 25 mL in 1 VIAL

Ingredients (1)

dalbavancin hydrochloride (500 mg/25mL)

Linked Drug Pages (1)

Dalbavancin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7fddacee-2401-4514-acf0-3847da11c6e5", "openfda": {"unii": ["33WDQ7T81E"], "rxcui": ["1539243"], "spl_set_id": ["1f4a5924-96d7-445a-b75f-2c0e1ffd2dea"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0480-3325-01)  / 25 mL in 1 VIAL", "package_ndc": "0480-3325-01", "marketing_start_date": "20251029"}], "brand_name": "Dalbavancin", "product_id": "0480-3325_7fddacee-2401-4514-acf0-3847da11c6e5", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Lipoglycopeptide Antibacterial [EPC]", "Lipoglycopeptides [CS]"], "product_ndc": "0480-3325", "generic_name": "Dalbavancin", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dalbavancin", "active_ingredients": [{"name": "DALBAVANCIN HYDROCHLORIDE", "strength": "500 mg/25mL"}], "application_number": "ANDA219465", "marketing_category": "ANDA", "marketing_start_date": "20251029", "listing_expiration_date": "20261231"}