FDA.reportPublic FDA data

VABOMERE

Product NDC
65293-009
11-digit product format
652930009
Labeler code
65293
Product ID
65293-009_580db23f-c656-3049-e053-2a91aa0ad616
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem-Vaborbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
The Medicines Company
Application
NDA209776
Marketing category
NDA
Marketing start
2017-10-02
Marketing end
0000-00-00
Substance
VABORBACTAM; MEROPENEM
Active strength
1 g/2g; g/2g
Pharmacologic classes
beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Carbapenems [CS],Penem Antibacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65293-009-062020-02-12C16284748780-19d75b9cf-dcfa-f424-e053-dadaa90a57ce580db23f-c655-3049-e053-2a91aa0ad616
65293-009-062020-01-31C16284748780-19d75b9cf-dcfa-f424-e053-dadaa90a57ce580db23f-c655-3049-e053-2a91aa0ad616

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65293-009-01EA - Each65293-0098cdae45a-db8d-4286-80fa-9ed1060b874612017-10-13
65293-009-06EA - Each65293-009cb143b36-93c9-43ab-ba11-ae1cef62799c12017-10-13