Vancomycin Hydrochloride
Vancomycin Hydrochloride for Injection, USP
Approved
Approval ID
91c050cf-3b2d-48bc-7297-e8dc68225e5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2022
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-1319
Application NumberANDA063076
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
FDA Product Classification
INGREDIENTS (3)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 5 mL
Code: 71WO621TJD
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
VANCOMYCIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-6509
Application NumberANDA063076
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
FDA Product Classification
INGREDIENTS (3)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 10 mL
Code: 71WO621TJD
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT