vancomycin hydrochloride

Generic: vancomycin hydrochloride

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

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vancomycin hydrochloride 1.5 g/1

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-0470
Product ID 39822-0470_4743ac39-0730-0f3d-e063-6394a90a8fc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215324
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398220470
Hyphenated Format 39822-0470

Supplemental Identifiers

RxCUI
2049888 2049890
UPC
0339822047024 0339822047017 0339822046027 0339822046010
UNII
71WO621TJD

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 vancomycin hydrochloride (source: ndc)
Generic Name vancomycin hydrochloride (source: ndc)
Application Number ANDA215324 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (39822-0470-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

39822-0470-2 10 VIAL in 1 CARTON (39822-0470-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

vancomycin hydrochloride (1.5 g/1)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4743ac39-0730-0f3d-e063-6394a90a8fc5", "openfda": {"upc": ["0339822047024", "0339822047017", "0339822046027", "0339822046010"], "unii": ["71WO621TJD"], "rxcui": ["2049888", "2049890"], "spl_set_id": ["4239165c-4c15-b78e-e063-6294a90ae6af"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (39822-0470-2)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "39822-0470-2", "marketing_start_date": "20251215"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "39822-0470_4743ac39-0730-0f3d-e063-6394a90a8fc5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "39822-0470", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "1.5 g/1"}], "application_number": "ANDA215324", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}