vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: xellia pharmaceuticals usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

vancomycin hydrochloride 500 mg/1

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-122
Product ID 70594-122_047a47f7-3fc4-4f77-aae1-a895c0f47e32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205694
Listing Expiration 2026-12-31
Marketing Start 2016-02-23

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594122
Hyphenated Format 70594-122

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 ANDA205694 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (70594-122-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-122-01)
source: ndc

Packages (1)

70594-122-02 10 VIAL, GLASS in 1 CARTON (70594-122-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-122-01)

Ingredients (1)

vancomycin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "047a47f7-3fc4-4f77-aae1-a895c0f47e32", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["1807513", "1807516"], "spl_set_id": ["8403695c-3614-490b-9797-6c5ebcdeef9b"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (70594-122-02)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-122-01)", "package_ndc": "70594-122-02", "marketing_start_date": "20231029"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "70594-122_047a47f7-3fc4-4f77-aae1-a895c0f47e32", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "70594-122", "generic_name": "vancomycin hydrochloride", "labeler_name": "Xellia Pharmaceuticals USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA205694", "marketing_category": "ANDA", "marketing_start_date": "20160223", "listing_expiration_date": "20261231"}