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FDA Approval

Vancomycin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
NorthStar Rx LLC
DUNS: 830546433
Effective Date
May 30, 2023
Labeling Type
Human Prescription Drug Label
Vancomycin(10 g in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Eugia Pharma Specialities Limited

NorthStar Rx LLC

650498244

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Vancomycin Hydrochloride

Product Details

NDC Product Code
16714-699
Application Number
ANDA205779
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 21, 2023
VancomycinActive
Code: 71WO621TJDClass: ACTIMQuantity: 10 g in 1 1

Vancomycin Hydrochloride

Product Details

NDC Product Code
16714-517
Application Number
ANDA205779
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 21, 2023
VancomycinActive
Code: 71WO621TJDClass: ACTIMQuantity: 5 g in 1 1
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