ruxience

Generic: rituximab-pvvr

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ruxience
Generic Name rituximab-pvvr
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rituximab 500 mg/50mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0249
Product ID 0069-0249_6d7dcd95-bbc2-4b1b-b044-5d6b06e3ca38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761103
Listing Expiration 2026-12-31
Marketing Start 2020-01-23

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 00690249
Hyphenated Format 0069-0249

Supplemental Identifiers

RxCUI
2273512 2273517 2273520 2273521
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 ruxience (source: ndc)
Generic Name rituximab-pvvr (source: ndc)
Application Number BLA761103 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0069-0249-01 1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

rituximab (500 mg/50mL)

Linked Drug Pages (1)

Ruxience ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6d7dcd95-bbc2-4b1b-b044-5d6b06e3ca38", "openfda": {"nui": ["N0000175078", "N0000175657"], "unii": ["4F4X42SYQ6"], "rxcui": ["2273512", "2273517", "2273520", "2273521"], "spl_set_id": ["f941fc61-f7a3-4e4a-ab7c-87c1667fa05b"], "pharm_class_epc": ["CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01)  / 50 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0069-0249-01", "marketing_start_date": "20200123"}], "brand_name": "Ruxience", "product_id": "0069-0249_6d7dcd95-bbc2-4b1b-b044-5d6b06e3ca38", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "0069-0249", "generic_name": "rituximab-pvvr", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ruxience", "active_ingredients": [{"name": "RITUXIMAB", "strength": "500 mg/50mL"}], "application_number": "BLA761103", "marketing_category": "BLA", "marketing_start_date": "20200123", "listing_expiration_date": "20261231"}