recarbrio

Generic: imipenem anhydrous, cilastatin, and relebactam anhydrous

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name recarbrio
Generic Name imipenem anhydrous, cilastatin, and relebactam anhydrous
Labeler merck sharp & dohme llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cilastatin 500 mg/100mL, imipenem anhydrous 500 mg/100mL, relebactam anhydrous 250 mg/100mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-3856
Product ID 0006-3856_11f74255-d000-4759-a561-136a5f13f667
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212819
Listing Expiration 2026-12-31
Marketing Start 2020-01-06

Pharmacologic Class

Established (EPC)
renal dehydropeptidase inhibitor [epc] penem antibacterial [epc] beta lactamase inhibitor [epc]
Mechanism of Action
dipeptidase inhibitors [moa] beta lactamase inhibitors [moa]
Chemical Structure
carbapenems [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00063856
Hyphenated Format 0006-3856

Supplemental Identifiers

RxCUI
2184142 2184147
UNII
141A6AMN38 Q20IM7HE75 1OQF7TT3PF
NUI
N0000175513 N0000175514 M0024174 N0000175496 N0000175930 N0000000202

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name recarbrio (source: ndc)
Generic Name imipenem anhydrous, cilastatin, and relebactam anhydrous (source: ndc)
Application Number NDA212819 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
  • 250 mg/100mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01)
source: ndc

Packages (1)

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

Ingredients (3)

cilastatin (500 mg/100mL) imipenem anhydrous (500 mg/100mL) relebactam anhydrous (250 mg/100mL)

Linked Drug Pages (1)

RECARBRIO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "11f74255-d000-4759-a561-136a5f13f667", "openfda": {"nui": ["N0000175513", "N0000175514", "M0024174", "N0000175496", "N0000175930", "N0000000202"], "unii": ["141A6AMN38", "Q20IM7HE75", "1OQF7TT3PF"], "rxcui": ["2184142", "2184147"], "spl_set_id": ["be32f468-738b-40df-a425-591e12f65159"], "pharm_class_cs": ["Carbapenems [CS]"], "pharm_class_epc": ["Renal Dehydropeptidase Inhibitor [EPC]", "Penem Antibacterial [EPC]", "beta Lactamase Inhibitor [EPC]"], "pharm_class_moa": ["Dipeptidase Inhibitors [MoA]", "beta Lactamase Inhibitors [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02)  / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01)", "package_ndc": "0006-3856-02", "marketing_start_date": "20200106"}], "brand_name": "RECARBRIO", "product_id": "0006-3856_11f74255-d000-4759-a561-136a5f13f667", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Dipeptidase Inhibitors [MoA]", "Penem Antibacterial [EPC]", "Renal Dehydropeptidase Inhibitor [EPC]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0006-3856", "generic_name": "imipenem anhydrous, cilastatin, and relebactam anhydrous", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RECARBRIO", "active_ingredients": [{"name": "CILASTATIN", "strength": "500 mg/100mL"}, {"name": "IMIPENEM ANHYDROUS", "strength": "500 mg/100mL"}, {"name": "RELEBACTAM ANHYDROUS", "strength": "250 mg/100mL"}], "application_number": "NDA212819", "marketing_category": "NDA", "marketing_start_date": "20200106", "listing_expiration_date": "20261231"}