Zemdri (plazomicin)
These highlights do not include all the information needed to use ZEMDRI™ safely and effectively. See full prescribing information for ZEMDRI. ZEMDRI (plazomicin) injection, for intravenous use Initial U.S. Approval: 2018
Approved
Approval ID
0b82ffed-27f4-4f5c-8135-670c148f0e12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2018
Manufacturers
FDA
Achaogen, Inc.
DUNS: 167293153
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Plazomicin
PRODUCT DETAILS
NDC Product Code71045-010
Application NumberNDA210303
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 29, 2018
Generic NamePlazomicin
INGREDIENTS (3)
plazomicinActive
Quantity: 500 mg in 10 mL
Code: LYO9XZ250J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT