vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vancomycin hydrochloride
Generic Name vancomycin hydrochloride
Labeler amneal pharmaceuticals ny llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

vancomycin hydrochloride 250 mg/5mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2261
Product ID 69238-2261_4709fe67-0ab3-4727-950f-b926a7bb21df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215338
Listing Expiration 2026-12-31
Marketing Start 2023-06-26

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382261
Hyphenated Format 69238-2261

Supplemental Identifiers

RxCUI
2000134
UPC
0369238226157 0369238226133 0369238226171
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 ANDA215338 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 80 mL in 1 BOTTLE (69238-2261-3)
  • 300 mL in 1 BOTTLE (69238-2261-5)
  • 150 mL in 1 BOTTLE (69238-2261-7)
source: ndc

Packages (3)

69238-2261-3 80 mL in 1 BOTTLE (69238-2261-3) 69238-2261-5 300 mL in 1 BOTTLE (69238-2261-5) 69238-2261-7 150 mL in 1 BOTTLE (69238-2261-7)

Ingredients (1)

vancomycin hydrochloride (250 mg/5mL)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4709fe67-0ab3-4727-950f-b926a7bb21df", "openfda": {"upc": ["0369238226157", "0369238226133", "0369238226171"], "unii": ["71WO621TJD"], "rxcui": ["2000134"], "spl_set_id": ["3c47d5c4-8cdb-4701-8d7a-8a6e79025b53"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "80 mL in 1 BOTTLE (69238-2261-3)", "package_ndc": "69238-2261-3", "marketing_start_date": "20230626"}, {"sample": false, "description": "300 mL in 1 BOTTLE (69238-2261-5)", "package_ndc": "69238-2261-5", "marketing_start_date": "20230626"}, {"sample": false, "description": "150 mL in 1 BOTTLE (69238-2261-7)", "package_ndc": "69238-2261-7", "marketing_start_date": "20230626"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "69238-2261_4709fe67-0ab3-4727-950f-b926a7bb21df", "dosage_form": "SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "69238-2261", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "250 mg/5mL"}], "application_number": "ANDA215338", "marketing_category": "ANDA", "marketing_start_date": "20230626", "listing_expiration_date": "20261231"}