Rifampin
Rifampin for Injection, USP
Approved
Approval ID
8be91604-d7cd-4f2b-997d-e3364e4092e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-445
Application NumberANDA065421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rifampin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 8, 2018
FDA Product Classification
INGREDIENTS (3)
RIFAMPINActive
Quantity: 600 mg in 10 mL
Code: VJT6J7R4TR
Classification: ACTIB
SODIUM FORMALDEHYDE SULFOXYLATEInactive
Code: X4ZGP7K714
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT