Rifadin IV NOVAPLUS
RIFADIN (rifampin capsules USP) and RIFADIN IV (rifampin for injection USP)
Approved
Approval ID
87839f65-cb33-412e-929e-564136501a84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Sanofi-Aventis U.S. LLC
DUNS: 824676584
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rifampin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0068-0599
Application NumberNDA050627
Product Classification
M
Marketing Category
C73594
G
Generic Name
rifampin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (3)
RIFAMPINActive
Quantity: 600 mg in 10 mL
Code: VJT6J7R4TR
Classification: ACTIB
SODIUM FORMALDEHYDE SULFOXYLATEInactive
Quantity: 10 mg in 10 mL
Code: X4ZGP7K714
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT