Vancomycin Hydrochloride
Vancomycin Hydrochloride for Injection, USP Fliptop Vial For Intravenous Use
Approved
Approval ID
f2901045-904f-47bd-74a1-c561facd7f25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 4
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 Code0409-6531
Application NumberANDA062912
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 7, 2023
FDA Product Classification
INGREDIENTS (3)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
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 Code0409-6533
Application NumberANDA062912
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 7, 2023
FDA Product Classification
INGREDIENTS (3)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: 71WO621TJD
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
VANCOMYCIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-3515
Application NumberANDA062912
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 7, 2023
FDA Product Classification
INGREDIENTS (3)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 1.5 g in 1 1
Code: 71WO621TJD
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
VANCOMYCIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-4332
Application NumberANDA062911
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 7, 2023
FDA Product Classification
INGREDIENTS (3)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 71WO621TJD
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT