NDC 0006-3856

RECARBRIO

Imipenem Anhydrous, Cilastatin, And Relebactam Anhydrous

RECARBRIO is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Imipenem Anhydrous; Cilastatin; Relebactam Anhydrous.

• Product ID: 0006-3856_3ab9872b-3ed8-41bd-a39c-b5ad1d3bc3dc
• NDC: 0006-3856
• Product Type: Human Prescription Drug
• Proprietary Name: RECARBRIO
• Generic Name: Imipenem Anhydrous, Cilastatin, And Relebactam Anhydrous
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-01-06
• Marketing Category: NDA / NDA
• Application Number: NDA212819
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: IMIPENEM ANHYDROUS; CILASTATIN; RELEBACTAM ANHYDROUS
• Active Ingredient Strength: 500 mg/100mL; mg/100mL; mg/100mL
• Pharm Classes: Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0006-3856-02

25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) > 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01)

• Marketing Start Date: 2020-01-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-3856-02 [00006385602]

RECARBRIO INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA212819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-06

NDC 0006-3856-01 [00006385601]

RECARBRIO INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA212819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-06

Drug Details

Active Ingredients

Ingredient	Strength
IMIPENEM ANHYDROUS	500 mg/100mL

Pharmacological Class

• Carbapenems [CS]
• Penem Antibacterial [EPC]
• Dipeptidase Inhibitors [MoA]
• Renal Dehydropeptidase Inhibitor [EPC]