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VANCOMYCIN HYDROCHLORIDE

Vancomycin Hydrochloride for Injection, USP Rx only For intravenous use. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Approved
Approval ID

3f5dacea-af40-4103-b128-c5e0c0c52fa1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 20, 2022

Manufacturers
FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

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 Code31722-211
Application NumberANDA216591
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 20, 2022
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 1 g in 20 mL
Code: 71WO621TJD
Classification: ACTIM

VANCOMYCIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-210
Application NumberANDA216591
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 20, 2022
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 10 mL
Code: 71WO621TJD
Classification: ACTIM

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VANCOMYCIN HYDROCHLORIDE - FDA Drug Approval Details