Sterile Vancomycin Hydrochloride
Sterile Vancomycin Hydrochloride USP 500 mg & 1 g
Approved
Approval ID
6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code21695-424
Application NumberANDA065397
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (4)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 10 mL
Code: 71WO621TJD
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT