VANCOMYCIN HYDROCHLORIDE
These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE FOR INJECTION. VANCOMYCIN HYDROCHLORIDE for injection, for intravenous use or oral useInitial U.S. Approval: 1958
Approved
Approval ID
e4ce7b87-fab4-4b7a-b121-eba136c464ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2023
Manufacturers
FDA
HIKMA PHARMACEUTICALS USA INC.
DUNS: 001230762
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 Code0143-9164
Application NumberNDA210274
Product Classification
M
Marketing Category
C73594
G
Generic Name
vancomycin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateFebruary 3, 2023
FDA Product Classification
INGREDIENTS (4)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 10.25 g in 1 g
Code: 71WO621TJD
Classification: ACTIM
TREHALOSEInactive
Quantity: 2.5 g in 1 g
Code: B8WCK70T7I
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 1 mg in 1 g
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
vancomycin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9163
Application NumberNDA210274
Product Classification
M
Marketing Category
C73594
G
Generic Name
vancomycin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateFebruary 3, 2023
FDA Product Classification
INGREDIENTS (4)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 5.13 g in 1 g
Code: 71WO621TJD
Classification: ACTIM
TREHALOSEInactive
Quantity: 1.25 g in 1 g
Code: B8WCK70T7I
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.5 mg in 1 g
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT