vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vancomycin hydrochloride 500 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-3551
Product ID 0338-3551_db8b59dd-edfd-4c37-b875-7e73f1f0bf35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050671
Listing Expiration 2026-12-31
Marketing Start 1958-11-14

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03383551
Hyphenated Format 0338-3551

Supplemental Identifiers

RxCUI
1807508 1807510 1807511 2118448 2387078
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 NDA050671 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 100 mL in 1 BAG (0338-3551-48)
source: ndc

Packages (1)

0338-3551-48 100 mL in 1 BAG (0338-3551-48)

Ingredients (1)

vancomycin hydrochloride (500 mg/100mL)

Linked Drug Pages (1)

VANCOMYCIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "db8b59dd-edfd-4c37-b875-7e73f1f0bf35", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["1807508", "1807510", "1807511", "2118448", "2387078"], "spl_set_id": ["99e523d8-9bde-43cb-8434-497015e5dcbd"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BAG (0338-3551-48)", "package_ndc": "0338-3551-48", "marketing_start_date": "19581114"}], "brand_name": "VANCOMYCIN HYDROCHLORIDE", "product_id": "0338-3551_db8b59dd-edfd-4c37-b875-7e73f1f0bf35", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "0338-3551", "generic_name": "VANCOMYCIN HYDROCHLORIDE", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VANCOMYCIN HYDROCHLORIDE", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "500 mg/100mL"}], "application_number": "NDA050671", "marketing_category": "NDA", "marketing_start_date": "19581114", "listing_expiration_date": "20261231"}