Vancomycin Hydrochloride
Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)
Approved
Approval ID
033efc76-11d5-4a93-91de-56ed41bab9c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vancomycin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-023
Application NumberANDA215197
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 11, 2022
FDA Product Classification
INGREDIENTS (1)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 1 g in 20 mL
Code: 71WO621TJD
Classification: ACTIM
Vancomycin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-022
Application NumberANDA215197
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 11, 2022
FDA Product Classification
INGREDIENTS (1)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 10 mL
Code: 71WO621TJD
Classification: ACTIM