FDA.reportPublic FDA data

VABOMERE

Product NDC
70842-120
11-digit product format
708420120
Labeler code
70842
Product ID
70842-120_163f9a07-823d-4c53-9136-8783e95f9cdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem-Vaborbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Melinta Therapeutics, LLC
Application
NDA209776
Marketing category
NDA
Marketing start
2017-10-02
Substance
MEROPENEM; VABORBACTAM
Active strength
1; 1 g/2g; g/2g
Pharmacologic classes
Carbapenems [CS], Penem Antibacterial [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VABOMERE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM1 g/2g
VABORBACTAM1 g/2g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFV9J3JU8B1, 1C75676F8V
Rxcui1945218, 1946651

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
437602ae-8b0a-4f4e-8f97-eabd2e27845eProduct name620250305
407c0246-8bda-450d-8667-f622a350d05cProduct name120231023
b1a98f8c-7b20-4bc2-b772-289c5d0949a9Product name120171106
940e5686-419d-4429-a15d-7bf46e26b176Product name120150929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70842-120-01VABOMERE2 g in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION214
70842-120-06VABOMERE6 in 1 CARTONINJECTION, POWDER, FOR SOLUTION614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70842-120-01EA - Each70842-12063dbb0e6-7963-4be1-bad7-5c4a3ecf2b6c12018-09-05
70842-120-06EA - Each70842-120f6c7b6aa-6f2b-4b92-95aa-132993866d3112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70842-120VABOMERE (MEROPENEM-VABORBACTAM) INJECTION, POWDER, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]13Current NDC, Legacy NDC, 2 package rows20250417_e237fd0f-3050-42a3-b43e-b6fb4824e93d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1945218meropenem / vaborbactam 2 GM InjectionPSNe237fd0f-3050-42a3-b43e-b6fb4824e93d14
1946651VABOMERE 2 GM InjectionPSNe237fd0f-3050-42a3-b43e-b6fb4824e93d14
1946651meropenem 1000 MG / vaborbactam 1000 MG Injection [Vabomere]SBDe237fd0f-3050-42a3-b43e-b6fb4824e93d14
1945218meropenem 1000 MG / vaborbactam 1000 MG InjectionSCDe237fd0f-3050-42a3-b43e-b6fb4824e93d14
1945218meropenem 1 GM / vaborbactam 1 GM InjectionSYe237fd0f-3050-42a3-b43e-b6fb4824e93d14
1946651Vabomere (meropenem / vaborbactam) 2 GM InjectionSYe237fd0f-3050-42a3-b43e-b6fb4824e93d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70842-120-01708420120012 g in 1 VIAL, SINGLE-DOSE2 gHistorical
70842-120-06708420120066 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01) 2017-10-020000-00-00NoNoCurrent