dalvance

Generic: dalbavancin

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

dalbavancin hydrochloride 500 mg/25mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 57970-100
Product ID 57970-100_c8fc5d09-57d1-4c85-aa4d-6bde6a25dcab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021883
Listing Expiration 2026-12-31
Marketing Start 2014-05-23

Pharmacologic Class

Classes
lipoglycopeptide antibacterial [epc] lipoglycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57970100
Hyphenated Format 57970-100

Supplemental Identifiers

RxCUI
1539243 1539248
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 dalvance (source: ndc)
Generic Name dalbavancin (source: ndc)
Application Number NDA021883 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/25mL
source: ndc
Packaging
  • 1 VIAL in 1 PACKAGE (57970-100-01) / 25 mL in 1 VIAL
source: ndc

Packages (1)

57970-100-01 1 VIAL in 1 PACKAGE (57970-100-01) / 25 mL in 1 VIAL

Ingredients (1)

dalbavancin hydrochloride (500 mg/25mL)

Linked Drug Pages (1)

DALVANCE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c8fc5d09-57d1-4c85-aa4d-6bde6a25dcab", "openfda": {"unii": ["33WDQ7T81E"], "rxcui": ["1539243", "1539248"], "spl_set_id": ["4b4674d8-4d1e-4728-8465-d42ada33fa5c"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 PACKAGE (57970-100-01)  / 25 mL in 1 VIAL", "package_ndc": "57970-100-01", "marketing_start_date": "20140523"}], "brand_name": "DALVANCE", "product_id": "57970-100_c8fc5d09-57d1-4c85-aa4d-6bde6a25dcab", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Lipoglycopeptide Antibacterial [EPC]", "Lipoglycopeptides [CS]"], "product_ndc": "57970-100", "generic_name": "Dalbavancin", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DALVANCE", "active_ingredients": [{"name": "DALBAVANCIN HYDROCHLORIDE", "strength": "500 mg/25mL"}], "application_number": "NDA021883", "marketing_category": "NDA", "marketing_start_date": "20140523", "listing_expiration_date": "20261231"}