Rapivab
These highlights do not include all the information needed to use RAPIVAB safely and effectively. See full prescribing information for RAPIVAB. RAPIVAB (peramivir injection), for intravenous useInitial U.S. Approval: [2014]
Approved
Approval ID
7fdedaec-9e53-4a37-a4e4-a301c8a251b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 17, 2020
Manufacturers
FDA
Seqirus USA Inc.
DUNS: 809197218
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
peramivir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61364-181
Application NumberNDA206426
Product Classification
M
Marketing Category
C73594
G
Generic Name
peramivir
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 17, 2020
FDA Product Classification
INGREDIENTS (5)
peramivirActive
Quantity: 600 mg in 60 mL
Code: QW7Y7ZR15U
Classification: ACTIM
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT