FDA.reportPublic FDA data

Nplate

Product NDC
55513-221
11-digit product format
555130221
Labeler code
55513
Product ID
55513-221_74d31919-0ed2-4e98-abd8-7cc3e011646b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
romiplostim
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA125268
Marketing category
BLA
Marketing start
2008-08-25
Substance
ROMIPLOSTIM
Active strength
250 ug/.5mL
Pharmacologic classes
Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nplate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROMIPLOSTIM250 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GN5XU2DXKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1728092Internal RxNorm lookup
1728095Internal RxNorm lookup
1728097Internal RxNorm lookup
1728099Internal RxNorm lookup
2201538Internal RxNorm lookup
2201540Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c45f9a58-37c1-4f76-8e36-97d38c577037Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc4fd77c-100a-4dc2-8dc4-32a97148e7b6Product name120190430
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-221-01Nplate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1161
55513-221-01Nplate0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,0.5161
55513-221-21Nplate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1161
55513-221-21Nplate0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,0.5161

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-221-01EA - Each55513-2219df07da6-48fb-4405-8bff-2aaa7dc6e69112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROMIPLOSTIMACTIVE INGREDIENTGN5XU2DXKVNPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]124
ROMIPLOSTIMACTIVE MOIETYGN5XU2DXKVNPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]124
HISTIDINEINACTIVE INGREDIENT4QD397987ENPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]124
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]124
MANNITOLINACTIVE INGREDIENT3OWL53L36ANPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]124
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]124
SUCROSEINACTIVE INGREDIENTC151H8M554NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-221NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN, INC]159Current NDC, Legacy NDC, 4 package rows20250309_c45f9a58-37c1-4f76-8e36-97d38c577037.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NplateROMIPLOSTIMAmgen, Incc45f9a58-37c1-4f76-8e36-97d38c5770372026-06-23Warnings, Adverse reactionsExact identifier
application number: BLA125268
ndc (product): 55513-221

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125268Nplateromiplostim351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2201540Nplate 125 MCG InjectionPSNc45f9a58-37c1-4f76-8e36-97d38c577037161
1728095Nplate 250 MCG InjectionPSNc45f9a58-37c1-4f76-8e36-97d38c577037161
1728099Nplate 500 MCG InjectionPSNc45f9a58-37c1-4f76-8e36-97d38c577037161
2201538romiPLOStim 125 MCG InjectionPSNc45f9a58-37c1-4f76-8e36-97d38c577037161
1728092romiPLOStim 250 MCG InjectionPSNc45f9a58-37c1-4f76-8e36-97d38c577037161
1728097romiPLOStim 500 MCG InjectionPSNc45f9a58-37c1-4f76-8e36-97d38c577037161
2201540romiplostim 0.125 MG Injection [Nplate]SBDc45f9a58-37c1-4f76-8e36-97d38c577037161
1728095romiplostim 0.25 MG Injection [Nplate]SBDc45f9a58-37c1-4f76-8e36-97d38c577037161
1728099romiplostim 0.5 MG Injection [Nplate]SBDc45f9a58-37c1-4f76-8e36-97d38c577037161
2201538romiplostim 0.125 MG InjectionSCDc45f9a58-37c1-4f76-8e36-97d38c577037161
1728092romiplostim 0.25 MG InjectionSCDc45f9a58-37c1-4f76-8e36-97d38c577037161
1728097romiplostim 0.5 MG InjectionSCDc45f9a58-37c1-4f76-8e36-97d38c577037161
2201540Nplate 0.125 MG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
1728095Nplate 0.25 MG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
1728099Nplate 0.5 MG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
2201540Nplate 125 MCG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
1728095Nplate 250 MCG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
1728099Nplate 500 MCG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
2201538romiplostim 125 MCG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
1728092romiplostim 250 MCG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161
1728097romiplostim 500 MCG InjectionSYc45f9a58-37c1-4f76-8e36-97d38c577037161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-221-01555130221011 VIAL in 1 CARTON (55513-221-01) / .5 mL in 1 VIAL1 vial2008-08-250000-00-00NoNoCurrent
55513-221-21555130221211 VIAL in 1 CARTON (55513-221-21) / .5 mL in 1 VIAL1 vial2025-08-01NoNoCurrent