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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71045-010
Application NumberNDA210303
Product Classification
M
Marketing Category
C73594
G
Generic Name
Plazomicin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 29, 2018
FDA Product Classification
INGREDIENTS (3)
plazomicinActive
Quantity: 500 mg in 10 mL
Code: LYO9XZ250J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT