vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

vancomycin hydrochloride 769 mg/mg

Manufacturer
HIKMA PHARMACEUTICALS USA INC.

Identifiers & Regulatory

Product NDC 0143-9473
Product ID 0143-9473_d17179c5-783a-487a-ab74-fb8ad3eb9c34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210274
Listing Expiration 2026-12-31
Marketing Start 2025-08-13

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439473
Hyphenated Format 0143-9473

Supplemental Identifiers

RxCUI
1807513 1807516 1807518 2049888 2049890
UPC
0301439474104 0301439475101 0301439473107
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 NDA210274 (source: ndc)
Routes
INTRAVENOUS ORAL
source: ndc

Resolved Composition

Strengths
  • 769 mg/mg
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (0143-9473-10) / 769 mg in 1 VIAL (0143-9473-01)
source: ndc

Packages (1)

0143-9473-10 10 VIAL in 1 PACKAGE (0143-9473-10) / 769 mg in 1 VIAL (0143-9473-01)

Ingredients (1)

vancomycin hydrochloride (769 mg/mg)

Linked Drug Pages (1)

VANCOMYCIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "ORAL"], "spl_id": "d17179c5-783a-487a-ab74-fb8ad3eb9c34", "openfda": {"upc": ["0301439474104", "0301439475101", "0301439473107"], "unii": ["71WO621TJD"], "rxcui": ["1807513", "1807516", "1807518", "2049888", "2049890"], "spl_set_id": ["8eccafe8-40c9-495a-872d-7f45a98ee759"], "manufacturer_name": ["HIKMA PHARMACEUTICALS USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (0143-9473-10)  / 769 mg in 1 VIAL (0143-9473-01)", "package_ndc": "0143-9473-10", "marketing_start_date": "20250813"}], "brand_name": "VANCOMYCIN HYDROCHLORIDE", "product_id": "0143-9473_d17179c5-783a-487a-ab74-fb8ad3eb9c34", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "0143-9473", "generic_name": "vancomycin hydrochloride", "labeler_name": "HIKMA PHARMACEUTICALS USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VANCOMYCIN HYDROCHLORIDE", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "769 mg/mg"}], "application_number": "NDA210274", "marketing_category": "NDA", "marketing_start_date": "20250813", "listing_expiration_date": "20261231"}