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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212819-001RECARBRIOCILASTATIN SODIUM; IMIPENEM; RELEBACTAMEQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIALPOWDER / INTRAVENOUSRLD, RS2019-07-16

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212819-00184870932033-03-21U-2586Drug substance, Drug product2019-08-13
N212819-00184870932033-03-21U-2587Drug substance, Drug product2019-08-13
N212819-00184870932033-03-21U-2840Drug substance, Drug product2019-08-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N212819-001NCE2024-07-16
N212819-001NPP2028-12-09
N212819-001GAIN2029-07-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N212819-001RECARBRIOEQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIALPOWDER / INTRAVENOUSRLD, RS2019-07-16a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N212819-00184870932033-03-21U-2587Drug substance, Drug product2019-08-13a50c72e98297…
2026-08-01 22:54:322026-06N212819-00184870932033-03-21U-2840Drug substance, Drug product2019-08-13a50c72e98297…
2026-08-01 22:54:322026-06N212819-00184870932033-03-21U-2586Drug substance, Drug product2019-08-13a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N212819-001NCE2024-07-16a50c72e98297…
2026-08-01 22:54:322026-06N212819-001NPP2028-12-09a50c72e98297…
2026-08-01 22:54:322026-06N212819-001GAIN2029-07-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RECARBRIOIMIPENEM ANHYDROUS, CILASTATIN, AND RELEBACTAM ANHYDROUSMerck Sharp & Dohme LLCbe32f468-738b-40df-a425-591e12f651592025-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 212819
application number: NDA212819
ndc (product): 0006-3856

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q20IM7HE75Internal UNII lookup
141A6AMN38Internal UNII lookup
1OQF7TT3PFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2184142Internal RxNorm lookup
2184147Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be32f468-738b-40df-a425-591e12f65159Available on FDA.report

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