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
NDC Product Code0409-1319
Application NumberANDA063076
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
Generic NameVANCOMYCIN HYDROCHLORIDE
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
NDC Product Code0409-6509
Application NumberANDA063076
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
Generic NameVANCOMYCIN HYDROCHLORIDE
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