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Vancomycin

These highlights do not include all the information needed to use VANCOMYCIN INJECTION, safely and effectively. See full prescribing information for VANCOMYCIN INJECTION. VANCOMYCIN injection, for intravenous use Initial U.S. Approval: 1958

Approved
Approval ID

60bee69b-be70-412c-9e83-a24a0a8a5e7b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 23, 2023

Manufacturers
FDA

Xellia Pharmaceuticals USA LLC

DUNS: 116768762

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Vancomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-043
Application NumberNDA211962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2020
FDA Product Classification

INGREDIENTS (1)

VANCOMYCINActive
Quantity: 1.5 g in 300 mL
Code: 6Q205EH1VU
Classification: ACTIB

Vancomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-056
Application NumberNDA211962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2020
FDA Product Classification

INGREDIENTS (1)

VANCOMYCINActive
Quantity: 750 mg in 150 mL
Code: 6Q205EH1VU
Classification: ACTIB

Vancomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-044
Application NumberNDA211962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2020
FDA Product Classification

INGREDIENTS (1)

VANCOMYCINActive
Quantity: 2 g in 400 mL
Code: 6Q205EH1VU
Classification: ACTIB

Vancomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-057
Application NumberNDA211962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2020
FDA Product Classification

INGREDIENTS (1)

VANCOMYCINActive
Quantity: 1.25 g in 250 mL
Code: 6Q205EH1VU
Classification: ACTIB

Vancomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-058
Application NumberNDA211962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2020
FDA Product Classification

INGREDIENTS (1)

VANCOMYCINActive
Quantity: 1.75 g in 350 mL
Code: 6Q205EH1VU
Classification: ACTIB

Vancomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-042
Application NumberNDA211962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2020
FDA Product Classification

INGREDIENTS (1)

VANCOMYCINActive
Quantity: 1 g in 200 mL
Code: 6Q205EH1VU
Classification: ACTIB

Vancomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-041
Application NumberNDA211962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2020
FDA Product Classification

INGREDIENTS (1)

VANCOMYCINActive
Quantity: 500 mg in 100 mL
Code: 6Q205EH1VU
Classification: ACTIB

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Vancomycin - FDA Drug Approval Details