vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vancomycin hydrochloride 1.5 g/1

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-597
Product ID 68083-597_16f3240c-d1ce-4407-ad09-565915a13805
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218140
Listing Expiration 2026-12-31
Marketing Start 2025-03-21

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083597
Hyphenated Format 68083-597

Supplemental Identifiers

RxCUI
1807518 2049888 2049890
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 ANDA218140 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 g/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01)
source: ndc

Packages (1)

68083-597-10 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01)

Ingredients (1)

vancomycin hydrochloride (1.5 g/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": "16f3240c-d1ce-4407-ad09-565915a13805", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["1807518", "2049888", "2049890"], "spl_set_id": ["65e5f2ee-934c-40d7-967c-00d085f84ffd"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01)", "package_ndc": "68083-597-10", "marketing_start_date": "20250321"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "68083-597_16f3240c-d1ce-4407-ad09-565915a13805", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "68083-597", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "1.5 g/1"}], "application_number": "ANDA218140", "marketing_category": "ANDA", "marketing_start_date": "20250321", "listing_expiration_date": "20261231"}