riabni

Generic: rituximab-arrx

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name riabni
Generic Name rituximab-arrx
Labeler amgen, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rituximab 100 mg/10mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-224
Product ID 55513-224_6fdd17d9-22be-41ef-bb0d-e3503855ff7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761140
Listing Expiration 2026-12-31
Marketing Start 2021-01-06

Pharmacologic Class

Established (EPC)
cd20-directed cytolytic antibody [epc]
Mechanism of Action
cd20-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513224
Hyphenated Format 55513-224

Supplemental Identifiers

RxCUI
2472327 2472332 2472335 2472336
UNII
4F4X42SYQ6
NUI
N0000175078 N0000175657

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name riabni (source: ndc)
Generic Name rituximab-arrx (source: ndc)
Application Number BLA761140 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-01) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-21) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55513-224-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-01) / 10 mL in 1 VIAL, SINGLE-DOSE 55513-224-21 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-21) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

rituximab (100 mg/10mL)

Linked Drug Pages (1)

Riabni ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6fdd17d9-22be-41ef-bb0d-e3503855ff7f", "openfda": {"nui": ["N0000175078", "N0000175657"], "unii": ["4F4X42SYQ6"], "rxcui": ["2472327", "2472332", "2472335", "2472336"], "spl_set_id": ["da1c4de7-0e5b-4f72-97ec-7a8d368f085f"], "pharm_class_epc": ["CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55513-224-01", "marketing_start_date": "20210106"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-21)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55513-224-21", "marketing_start_date": "20250721"}], "brand_name": "Riabni", "product_id": "55513-224_6fdd17d9-22be-41ef-bb0d-e3503855ff7f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "55513-224", "generic_name": "rituximab-arrx", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Riabni", "active_ingredients": [{"name": "RITUXIMAB", "strength": "100 mg/10mL"}], "application_number": "BLA761140", "marketing_category": "BLA", "marketing_start_date": "20210106", "listing_expiration_date": "20261231"}