Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amgen Manufacturing Ltd
Amgen Inc
785800020
Immunex Rhode Island Corporation
Amgen Inc
968084785
Amgen, Inc
Amgen Inc
039976196
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nplate
Product Details
NDC Product Code
55513-223Application Number
BLA125268Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
February 17, 2022HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 2.5 mmol in 0.25 mL
RomiplostimActive
Code: GN5XU2DXKVClass: ACTIBQuantity: 125 ug in 0.25 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 10 mg in 0.25 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.01 mg in 0.25 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 5 mg in 0.25 mL
Nplate
Product Details
NDC Product Code
55513-222Application Number
BLA125268Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
February 17, 2022HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
RomiplostimActive
Code: GN5XU2DXKVClass: ACTIBQuantity: 500 ug in 1 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 10 mmol in 1 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.04 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 40 mg in 1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 20 mg in 1 mL
Nplate
Product Details
NDC Product Code
55513-221Application Number
BLA125268Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
February 17, 2022RomiplostimActive
Code: GN5XU2DXKVClass: ACTIBQuantity: 250 ug in 0.5 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 5 mmol in 0.5 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.02 mg in 0.5 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 20 mg in 0.5 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 10 mg in 0.5 mL