RECARBRIO
These highlights do not include all the information needed to use RECARBRIO safely and effectively. See full prescribing information for RECARBRIO. RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, for intravenous use Initial U.S. Approval: 2019
Approved
Approval ID
be32f468-738b-40df-a425-591e12f65159
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
imipenem anhydrous, cilastatin, and relebactam anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-3856
Application NumberNDA212819
Product Classification
M
Marketing Category
C73594
G
Generic Name
imipenem anhydrous, cilastatin, and relebactam anhydrous
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 5, 2022
FDA Product Classification
INGREDIENTS (4)
IMIPENEM ANHYDROUSActive
Quantity: 500 mg in 100 mL
Code: Q20IM7HE75
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 20 mg in 100 mL
Code: 8MDF5V39QO
Classification: IACT
CILASTATINActive
Quantity: 500 mg in 100 mL
Code: 141A6AMN38
Classification: ACTIB
RELEBACTAM ANHYDROUSActive
Quantity: 250 mg in 100 mL
Code: 1OQF7TT3PF
Classification: ACTIB