Portrazza
These highlights do not include all the information needed to use PORTRAZZA safely and effectively. See full prescribing information for PORTRAZZA. PORTRAZZA (necitumumab) injection, for intravenous useInitial U.S. Approval: 2015
Approved
Approval ID
89bcf553-669a-40b0-a9d7-67a5c1d2f591
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
necitumumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-7716
Application NumberBLA125547
Product Classification
M
Marketing Category
C73585
G
Generic Name
necitumumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 3, 2017
FDA Product Classification
INGREDIENTS (8)
MannitolInactive
Quantity: 9.109 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
necitumumabActive
Quantity: 16 mg in 1 mL
Code: 2BT4C47RUI
Classification: ACTIB
Anhydrous Citric AcidInactive
Quantity: 0.256 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
GlycineInactive
Quantity: 9.984 mg in 1 mL
Code: TE7660XO1C
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
Sodium ChlorideInactive
Quantity: 2.338 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Trisodium Citrate DihydrateInactive
Quantity: 2.55 mg in 1 mL
Code: B22547B95K
Classification: IACT