vancomycin hydrochloride

Generic: vancomycin hydrochloride

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

Drug Facts

Product Profile

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

vancomycin hydrochloride 500 mg/10mL

Manufacturer
Medimetriks Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43538-805
Product ID 43538-805_1ad6b244-4759-43d1-aae0-81580193759e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065401
Listing Expiration 2026-12-31
Marketing Start 2008-06-30

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43538805
Hyphenated Format 43538-805

Supplemental Identifiers

RxCUI
1807513 1807516
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 ANDA065401 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (43538-805-10) / 10 mL in 1 VIAL, GLASS (43538-805-01)
source: ndc

Packages (1)

43538-805-10 10 VIAL, GLASS in 1 CARTON (43538-805-10) / 10 mL in 1 VIAL, GLASS (43538-805-01)

Ingredients (1)

vancomycin hydrochloride (500 mg/10mL)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1ad6b244-4759-43d1-aae0-81580193759e", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["1807513", "1807516"], "spl_set_id": ["826510bd-b611-42d9-a574-ec7ee4151ef5"], "manufacturer_name": ["Medimetriks Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (43538-805-10)  / 10 mL in 1 VIAL, GLASS (43538-805-01)", "package_ndc": "43538-805-10", "marketing_start_date": "20250402"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "43538-805_1ad6b244-4759-43d1-aae0-81580193759e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "43538-805", "generic_name": "Vancomycin hydrochloride", "labeler_name": "Medimetriks Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "500 mg/10mL"}], "application_number": "ANDA065401", "marketing_category": "ANDA", "marketing_start_date": "20080630", "listing_expiration_date": "20261231"}