FDA.reportPublic FDA data

RECARBRIO

Product NDC
0006-3856
11-digit product format
000063856
Labeler code
0006
Product ID
0006-3856_11f74255-d000-4759-a561-136a5f13f667
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imipenem anhydrous, cilastatin, and relebactam anhydrous
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA212819
Marketing category
NDA
Marketing start
2020-01-06
Substance
CILASTATIN; IMIPENEM ANHYDROUS; RELEBACTAM ANHYDROUS
Active strength
500; 500; 250 mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RECARBRIO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CILASTATIN500 mg/100mL
IMIPENEM ANHYDROUS500 mg/100mL
RELEBACTAM ANHYDROUS250 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii141A6AMN38, Q20IM7HE75, 1OQF7TT3PF
Rxcui2184142, 2184147

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
bd5bade3-1b69-46d8-87bd-7d2fbe32b767Product name120200603
bc64ce14-a963-4b05-9b71-737977847052Product name120191008
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3856-01RECARBRIO20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2011
0006-3856-02RECARBRIO25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3856-01EA - Each0006-385638e435cb-5843-478d-a005-4c53433f6ffe12020-02-13
0006-3856-02EA - Each0006-3856e65e4522-e668-441c-99b1-8048e6d4309612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3856RECARBRIO (IMIPENEM ANHYDROUS, CILASTATIN, AND RELEBACTAM ANHYDROUS) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME LLC]9Current NDC, Legacy NDC, 2 package rows20241107_be32f468-738b-40df-a425-591e12f65159.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2184142cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG InjectionPSNbe32f468-738b-40df-a425-591e12f6515911
2184147Recarbrio 500 MG / 500 MG / 250 MG InjectionPSNbe32f468-738b-40df-a425-591e12f6515911
2184147cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG Injection [Recarbrio]SBDbe32f468-738b-40df-a425-591e12f6515911
2184142cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG InjectionSCDbe32f468-738b-40df-a425-591e12f6515911
2184147Recarbrio 1.25 GM InjectionSYbe32f468-738b-40df-a425-591e12f6515911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-3856-010000638560120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0006-3856-020000638560225 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01) 2020-01-060000-00-00NoNoCurrent