FDA.reportPublic FDA data

Nplate

Product NDC
55513-223
11-digit product format
555130223
Labeler code
55513
Product ID
55513-223_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
2019-08-02
Substance
ROMIPLOSTIM
Active strength
125 ug/.25mL
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 55513-223

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROMIPLOSTIM125 ug/.25mL

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
55513-223-01Nplate0.25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,0.25161
55513-223-01Nplate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1161
55513-223-21Nplate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1161
55513-223-21Nplate0.25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,0.25161

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-223-01EA - Each55513-22397b2822a-402a-41d1-b214-528258c62c9712019-12-10
55513-223-21EA - Each55513-223e4b2f6be-ab5a-4a88-99b8-17661b9b942512026-01-08

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
55513-223NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN, INC]159Current NDC, Legacy NDC, 4 package rows20250309_c45f9a58-37c1-4f76-8e36-97d38c577037.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125268Nplateromiplostim351(a)Rx2026-06-01

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-223-01555130223011 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) / .25 mL in 1 VIAL, SINGLE-DOSE2019-08-020000-00-00NoNoCurrent
55513-223-21555130223211 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-21) / .25 mL in 1 VIAL, SINGLE-DOSE2025-08-01NoNoCurrent