FDA.reportPublic FDA data

Riabni

Product NDC
55513-326
11-digit product format
555130326
Labeler code
55513
Product ID
55513-326_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
500 mg/50mL
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITUXIMAB500 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4F4X42SYQ6
Rxcui2472327, 2472332, 2472335, 2472336

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
55513-326-01Riabni1 in 1 CARTONINJECTION, SOLUTION19
55513-326-01Riabni50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION509
55513-326-21Riabni50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION509
55513-326-21Riabni1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-326-01ML - Milliliter55513-326180ef222-6b9b-4ed4-9fdf-3843987e865212021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-326RIABNI (RITUXIMAB-ARRX) INJECTION, SOLUTION [AMGEN INC]6Current NDC, Legacy NDC, 4 package rows20240308_da1c4de7-0e5b-4f72-97ec-7a8d368f085f.zip

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
55513-326-01555130326011 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-01) / 50 mL in 1 VIAL, SINGLE-DOSE2021-01-060000-00-00NoNoCurrent
55513-326-21555130326211 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-21) / 50 mL in 1 VIAL, SINGLE-DOSE2025-07-21NoNoHistorical