dalbavancin

Generic: dalbavancin

Labeler: meitheal pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dalbavancin hydrochloride 500 mg/25mL

Manufacturer
Meitheal Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 71288-034
Product ID 71288-034_eb1f6798-3443-4fa7-95fc-fe4a387de46d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218929
Listing Expiration 2026-12-31
Marketing Start 2025-11-26

Pharmacologic Class

Classes
lipoglycopeptide antibacterial [epc] lipoglycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288034
Hyphenated Format 71288-034

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 ANDA218929 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/25mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-034-50) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-034-50 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-034-50) / 25 mL in 1 VIAL, SINGLE-DOSE

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": "eb1f6798-3443-4fa7-95fc-fe4a387de46d", "openfda": {"unii": ["33WDQ7T81E"], "rxcui": ["1539243"], "spl_set_id": ["966995bb-9d92-434d-b75a-1786072b81c9"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-034-50)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-034-50", "marketing_start_date": "20251126"}], "brand_name": "Dalbavancin", "product_id": "71288-034_eb1f6798-3443-4fa7-95fc-fe4a387de46d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipoglycopeptide Antibacterial [EPC]", "Lipoglycopeptides [CS]"], "product_ndc": "71288-034", "generic_name": "Dalbavancin", "labeler_name": "Meitheal Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dalbavancin", "active_ingredients": [{"name": "DALBAVANCIN HYDROCHLORIDE", "strength": "500 mg/25mL"}], "application_number": "ANDA218929", "marketing_category": "ANDA", "marketing_start_date": "20251126", "listing_expiration_date": "20261231"}