vabomere

Generic: meropenem-vaborbactam

Labeler: melinta therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vabomere
Generic Name meropenem-vaborbactam
Labeler melinta therapeutics, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

meropenem 1 g/2g, vaborbactam 1 g/2g

Manufacturer
Melinta Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70842-120
Product ID 70842-120_163f9a07-823d-4c53-9136-8783e95f9cdc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209776
Listing Expiration 2027-12-31
Marketing Start 2017-10-02

Pharmacologic Class

Established (EPC)
beta lactamase inhibitor [epc]
Mechanism of Action
beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70842120
Hyphenated Format 70842-120

Supplemental Identifiers

RxCUI
1945218 1946651
UNII
FV9J3JU8B1 1C75676F8V
NUI
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 vabomere (source: ndc)
Generic Name meropenem-vaborbactam (source: ndc)
Application Number NDA209776 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/2g
source: ndc
Packaging
  • 6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01)
source: ndc

Packages (1)

70842-120-06 6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01)

Ingredients (2)

meropenem (1 g/2g) vaborbactam (1 g/2g)

Linked Drug Pages (1)

VABOMERE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "163f9a07-823d-4c53-9136-8783e95f9cdc", "openfda": {"nui": ["N0000175930", "N0000000202"], "unii": ["FV9J3JU8B1", "1C75676F8V"], "rxcui": ["1945218", "1946651"], "spl_set_id": ["e237fd0f-3050-42a3-b43e-b6fb4824e93d"], "pharm_class_epc": ["beta Lactamase Inhibitor [EPC]"], "pharm_class_moa": ["beta Lactamase Inhibitors [MoA]"], "manufacturer_name": ["Melinta Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06)  / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01)", "package_ndc": "70842-120-06", "marketing_start_date": "20171002"}], "brand_name": "VABOMERE", "product_id": "70842-120_163f9a07-823d-4c53-9136-8783e95f9cdc", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "70842-120", "generic_name": "Meropenem-Vaborbactam", "labeler_name": "Melinta Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VABOMERE", "active_ingredients": [{"name": "MEROPENEM", "strength": "1 g/2g"}, {"name": "VABORBACTAM", "strength": "1 g/2g"}], "application_number": "NDA209776", "marketing_category": "NDA", "marketing_start_date": "20171002", "listing_expiration_date": "20271231"}