vancomycin hydrochloride

Generic: vancomycin hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

vancomycin hydrochloride 500 mg/10mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-150
Product ID 25021-150_9421f884-7b57-4a9a-8389-a45a70dd4598
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205694
Listing Expiration 2026-12-31
Marketing Start 2023-07-15

Pharmacologic Class

Classes
glycopeptide antibacterial [epc] glycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021150
Hyphenated Format 25021-150

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 ANDA205694 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-150-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

25021-150-10 10 VIAL in 1 CARTON (25021-150-10) / 10 mL in 1 VIAL

Ingredients (1)

vancomycin hydrochloride (500 mg/10mL)

Linked Drug Pages (1)

Vancomycin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9421f884-7b57-4a9a-8389-a45a70dd4598", "openfda": {"unii": ["71WO621TJD"], "rxcui": ["1807513", "1807516"], "spl_set_id": ["4843726f-6e79-6e20-2620-4a54616e6479"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-150-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-150-10", "marketing_start_date": "20230715"}], "brand_name": "Vancomycin Hydrochloride", "product_id": "25021-150_9421f884-7b57-4a9a-8389-a45a70dd4598", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glycopeptide Antibacterial [EPC]", "Glycopeptides [CS]"], "product_ndc": "25021-150", "generic_name": "vancomycin hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vancomycin Hydrochloride", "active_ingredients": [{"name": "VANCOMYCIN HYDROCHLORIDE", "strength": "500 mg/10mL"}], "application_number": "ANDA205694", "marketing_category": "ANDA", "marketing_start_date": "20230715", "listing_expiration_date": "20261231"}