FDA.reportPublic FDA data

Riabni

Product NDC
55513-224
11-digit product format
555130224
Labeler code
55513
Product ID
55513-224_6fdd17d9-22be-41ef-bb0d-e3503855ff7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rituximab-arrx
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amgen, Inc
Application
BLA761140
Marketing category
BLA
Marketing start
2021-01-06
Substance
RITUXIMAB
Active strength
100 mg/10mL
Pharmacologic classes
CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITUXIMAB100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4F4X42SYQ6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2472327Internal RxNorm lookup
2472332Internal RxNorm lookup
2472335Internal RxNorm lookup
2472336Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da1c4de7-0e5b-4f72-97ec-7a8d368f085fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
37187acd-f290-495b-addd-d6d252de503bProduct name120210609
53df6cbe-2f85-495d-8a25-0d580b91ff46Product name120180806
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-224-01Riabni1 in 1 CARTONINJECTION, SOLUTION19
55513-224-01Riabni10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
55513-224-21Riabni1 in 1 CARTONINJECTION, SOLUTION19
55513-224-21Riabni10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-224-01ML - Milliliter55513-224a3105abe-0405-4bf7-97f7-4de2219fbc5412021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-224RIABNI (RITUXIMAB-ARRX) INJECTION, SOLUTION [AMGEN INC]6Current NDC, Legacy NDC, 4 package rows20240308_da1c4de7-0e5b-4f72-97ec-7a8d368f085f.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
RiabniRITUXIMAB-ARRXAmgen, Incda1c4de7-0e5b-4f72-97ec-7a8d368f085f2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761140
ndc (product): 55513-224

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761140Riabnirituximab-arrx351(k) BiosimilarRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2472332RIABNI 100 MG in 10 ML InjectionPSNda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
2472336RIABNI 500 MG in 50 ML InjectionPSNda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
2472327riTUXimab-arrx 100 MG in 10 ML InjectionPSNda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
2472335riTUXimab-arrx 500 MG in 50 ML InjectionPSNda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
247233210 ML rituximab-arrx 10 MG/ML Injection [Riabni]SBDda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
247233650 ML rituximab-arrx 10 MG/ML Injection [Riabni]SBDda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
247232710 ML rituximab-arrx 10 MG/ML InjectionSCDda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
247233550 ML rituximab-arrx 10 MG/ML InjectionSCDda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
247233210 ML Riabni 10 MG/ML InjectionSYda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
247233650 ML Riabni 10 MG/ML InjectionSYda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
2472332Riabni 100 MG per 10 ML InjectionSYda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
2472336Riabni 500 MG per 50 ML InjectionSYda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
2472327rituximab-arrx 100 MG per 10 ML InjectionSYda1c4de7-0e5b-4f72-97ec-7a8d368f085f9
2472335rituximab-arrx 500 MG per 50 ML InjectionSYda1c4de7-0e5b-4f72-97ec-7a8d368f085f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-224-01555130224011 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-01) / 10 mL in 1 VIAL, SINGLE-DOSE2021-01-060000-00-00NoNoCurrent
55513-224-21555130224211 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-21) / 10 mL in 1 VIAL, SINGLE-DOSE2025-07-21NoNoCurrent