vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

vancomycin hydrochloride 250 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0514
Product ID 80425-0514_331277b8-8300-d082-e063-6394a90a4dd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050606
Listing Expiration 2026-12-31
Marketing Start 2025-04-18

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250514
Hyphenated Format 80425-0514

Supplemental Identifiers

RxCUI
313571
UNII
71WO621TJD

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 NDA050606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (80425-0514-1)
  • 30 CAPSULE in 1 BOTTLE (80425-0514-2)
  • 60 CAPSULE in 1 BOTTLE (80425-0514-3)
  • 90 CAPSULE in 1 BOTTLE (80425-0514-4)
  • 40 CAPSULE in 1 BOTTLE (80425-0514-5)
  • 50 CAPSULE in 1 BOTTLE (80425-0514-6)
source: ndc

Packages (6)

80425-0514-1 20 CAPSULE in 1 BOTTLE (80425-0514-1) 80425-0514-2 30 CAPSULE in 1 BOTTLE (80425-0514-2) 80425-0514-3 60 CAPSULE in 1 BOTTLE (80425-0514-3) 80425-0514-4 90 CAPSULE in 1 BOTTLE (80425-0514-4) 80425-0514-5 40 CAPSULE in 1 BOTTLE (80425-0514-5) 80425-0514-6 50 CAPSULE in 1 BOTTLE (80425-0514-6)

Ingredients (1)

vancomycin hydrochloride (250 mg/1)

Linked Drug Pages (1)

vancomycin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "331277b8-8300-d082-e063-6394a90a4dd3", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["313571"], "spl_set_id": ["33127951-1fad-15c1-e063-6294a90a6996"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (80425-0514-1)", "package_ndc": "80425-0514-1", "marketing_start_date": "20250418"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0514-2)", "package_ndc": "80425-0514-2", "marketing_start_date": "20250418"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (80425-0514-3)", "package_ndc": "80425-0514-3", "marketing_start_date": "20250418"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (80425-0514-4)", "package_ndc": "80425-0514-4", "marketing_start_date": "20250418"}, {"sample": false, "description": "40 CAPSULE in 1 BOTTLE (80425-0514-5)", "package_ndc": "80425-0514-5", "marketing_start_date": "20250418"}, {"sample": false, "description": "50 CAPSULE in 1 BOTTLE (80425-0514-6)", "package_ndc": "80425-0514-6", "marketing_start_date": "20250418"}], "brand_name": "vancomycin hydrochloride", "product_id": "80425-0514_331277b8-8300-d082-e063-6394a90a4dd3", "dosage_form": "CAPSULE", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "80425-0514", "generic_name": "vancomycin hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "vancomycin hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "NDA050606", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250418", "listing_expiration_date": "20261231"}