Nplate
These highlights do not include all the information needed to use NPLATE safely and effectively. See full prescribing information for NPLATE. N PLATE (romiplostim) for injection , for subcutaneous use Initial U.S. Approval: 2008
Approved
Approval ID
c45f9a58-37c1-4f76-8e36-97d38c577037
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2022
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
romiplostim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-223
Application NumberBLA125268
Product Classification
M
Marketing Category
C73585
G
Generic Name
romiplostim
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 17, 2022
FDA Product Classification
INGREDIENTS (6)
HISTIDINEInactive
Quantity: 2.5 mmol in 0.25 mL
Code: 4QD397987E
Classification: IACT
ROMIPLOSTIMActive
Quantity: 125 ug in 0.25 mL
Code: GN5XU2DXKV
Classification: ACTIB
MANNITOLInactive
Quantity: 10 mg in 0.25 mL
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.01 mg in 0.25 mL
Code: 7T1F30V5YH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SUCROSEInactive
Quantity: 5 mg in 0.25 mL
Code: C151H8M554
Classification: IACT
romiplostim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-222
Application NumberBLA125268
Product Classification
M
Marketing Category
C73585
G
Generic Name
romiplostim
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 17, 2022
FDA Product Classification
INGREDIENTS (6)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ROMIPLOSTIMActive
Quantity: 500 ug in 1 mL
Code: GN5XU2DXKV
Classification: ACTIB
HISTIDINEInactive
Quantity: 10 mmol in 1 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.04 mg in 1 mL
Code: 7T1F30V5YH
Classification: IACT
MANNITOLInactive
Quantity: 40 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
SUCROSEInactive
Quantity: 20 mg in 1 mL
Code: C151H8M554
Classification: IACT
romiplostim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-221
Application NumberBLA125268
Product Classification
M
Marketing Category
C73585
G
Generic Name
romiplostim
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 17, 2022
FDA Product Classification
INGREDIENTS (6)
ROMIPLOSTIMActive
Quantity: 250 ug in 0.5 mL
Code: GN5XU2DXKV
Classification: ACTIB
HISTIDINEInactive
Quantity: 5 mmol in 0.5 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.02 mg in 0.5 mL
Code: 7T1F30V5YH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MANNITOLInactive
Quantity: 20 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 0.5 mL
Code: C151H8M554
Classification: IACT