vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

vancomycin hydrochloride 1 g/20mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-023
Product ID 71288-023_8783ba3b-c343-44ba-9a51-516751993478
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215197
Listing Expiration 2026-12-31
Marketing Start 2022-07-28

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288023
Hyphenated Format 71288-023

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 ANDA215197 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/20mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-023-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-023-20)
source: ndc

Packages (1)

71288-023-21 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-023-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-023-20)

Ingredients (1)

vancomycin hydrochloride (1 g/20mL)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8783ba3b-c343-44ba-9a51-516751993478", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["1807513", "1807516"], "spl_set_id": ["033efc76-11d5-4a93-91de-56ed41bab9c3"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-023-21)  / 20 mL in 1 VIAL, SINGLE-DOSE (71288-023-20)", "package_ndc": "71288-023-21", "marketing_start_date": "20220728"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "71288-023_8783ba3b-c343-44ba-9a51-516751993478", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "71288-023", "generic_name": "Vancomycin Hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "1 g/20mL"}], "application_number": "ANDA215197", "marketing_category": "ANDA", "marketing_start_date": "20220728", "listing_expiration_date": "20261231"}