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 5.13 g/g

Manufacturer
HIKMA PHARMACEUTICALS USA INC.

Identifiers & Regulatory

Product NDC 0143-9163
Product ID 0143-9163_0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210274
Listing Expiration 2026-12-31
Marketing Start 2023-02-03

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439163
Hyphenated Format 0143-9163

Supplemental Identifiers

RxCUI
239209
UPC
0301439163015 0301439164012
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
  • 5.13 g/g
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

0143-9163-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (1)

vancomycin hydrochloride (5.13 g/g)

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": "0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f", "openfda": {"upc": ["0301439163015", "0301439164012"], "unii": ["71WO621TJD"], "rxcui": ["239209"], "spl_set_id": ["e4ce7b87-fab4-4b7a-b121-eba136c464ce"], "manufacturer_name": ["HIKMA PHARMACEUTICALS USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01)  / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "0143-9163-01", "marketing_start_date": "20230203"}], "brand_name": "VANCOMYCIN HYDROCHLORIDE", "product_id": "0143-9163_0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "0143-9163", "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": "5.13 g/g"}], "application_number": "NDA210274", "marketing_category": "NDA", "marketing_start_date": "20230203", "listing_expiration_date": "20261231"}