vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vancomycin hydrochloride 500 mg/10mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-221
Product ID 63323-221_7b9b7963-befb-46bd-8357-a61be3d0ba9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062663
Listing Expiration 2026-12-31
Marketing Start 2021-05-03

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323221
Hyphenated Format 63323-221

Supplemental Identifiers

RxCUI
1807513 1807516
UPC
0363323284428 0363323221416
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 ANDA062663 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-221-16) / 10 mL in 1 VIAL (63323-221-41)
source: ndc

Packages (1)

63323-221-16 25 VIAL in 1 TRAY (63323-221-16) / 10 mL in 1 VIAL (63323-221-41)

Ingredients (1)

vancomycin hydrochloride (500 mg/10mL)

Linked Drug Pages (4)

Vancomycin Hydrochloride ndc-match (0.9) Vancomycin Hydrochloride ndc-match (0.9) VANCOMYCIN HYDROCHLORIDE ndc-match (0.9) VANCOMYCIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7b9b7963-befb-46bd-8357-a61be3d0ba9e", "openfda": {"upc": ["0363323284428", "0363323221416"], "unii": ["71WO621TJD"], "rxcui": ["1807513", "1807516"], "spl_set_id": ["0576803d-95de-4a48-806a-69ae3fcaf6b0"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-221-16)  / 10 mL in 1 VIAL (63323-221-41)", "package_ndc": "63323-221-16", "marketing_start_date": "20210503"}], "brand_name": "VANCOMYCIN HYDROCHLORIDE", "product_id": "63323-221_7b9b7963-befb-46bd-8357-a61be3d0ba9e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "63323-221", "generic_name": "VANCOMYCIN HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VANCOMYCIN HYDROCHLORIDE", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "500 mg/10mL"}], "application_number": "ANDA062663", "marketing_category": "ANDA", "marketing_start_date": "20210503", "listing_expiration_date": "20261231"}