vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

vancomycin hydrochloride 750 mg/1

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-477
Product ID 68462-477_210eb04c-a542-44da-b4a3-7e243186b483
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 68462477
Hyphenated Format 68462-477

Supplemental Identifiers

RxCUI
1807518 2049888 2049890
UPC
0368462478844 0368462477748 0368462479841
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
  • 750 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-477-74) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68462-477-20)
source: ndc

Packages (1)

68462-477-74 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-477-74) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68462-477-20)

Ingredients (1)

vancomycin hydrochloride (750 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": "210eb04c-a542-44da-b4a3-7e243186b483", "openfda": {"upc": ["0368462478844", "0368462477748", "0368462479841"], "unii": ["71WO621TJD"], "rxcui": ["1807518", "2049888", "2049890"], "spl_set_id": ["0543b2b5-b1c7-4ad6-b38c-3be0086f0e06"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68462-477-74)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68462-477-20)", "package_ndc": "68462-477-74", "marketing_start_date": "20250321"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "68462-477_210eb04c-a542-44da-b4a3-7e243186b483", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "68462-477", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA218140", "marketing_category": "ANDA", "marketing_start_date": "20250321", "listing_expiration_date": "20261231"}