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FDA Approval

RECARBRIO

CompanyMerck Sharp & Dohme LLC (DUNS: 118446553)

Effective Date

July 26, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Imipenem(500 mg in 100 mL)

Cilastatin(500 mg in 100 mL)

Relebactam(250 mg in 100 mL)

Products (1)

RECARBRIO

NDC Product Code

0006-3856

Application Number

NDA212819

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

May 5, 2022

Ingredients

Code: Q20IM7HE75Class: ACTIBQuantity: 500 mg in 100 mL

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACTQuantity: 20 mg in 100 mL

CilastatinActive

Code: 141A6AMN38Class: ACTIBQuantity: 500 mg in 100 mL

RelebactamActive

Code: 1OQF7TT3PFClass: ACTIBQuantity: 250 mg in 100 mL

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