FDA.reportPublic FDA data

Ruxience

Product NDC
0069-0249
11-digit product format
000690249
Labeler code
0069
Product ID
0069-0249_87be604a-12ed-4b20-a7bc-8a69258abcf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rituximab-pvvr
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761103
Marketing category
BLA
Marketing start
2020-01-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITUXIMAB500 mg/50mL

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
2273512Internal RxNorm lookup
2273517Internal RxNorm lookup
2273520Internal RxNorm lookup
2273521Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f941fc61-f7a3-4e4a-ab7c-87c1667fa05bAvailable 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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0249-01Ruxience50 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION5011
0069-0249-01Ruxience1 in 1 CARTONINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0249-01ML - Milliliter0069-02490a03c885-13be-4de2-a940-5319432baef412020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0249RUXIENCE (RITUXIMAB-PVVR) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]9Current NDC, Legacy NDC, 2 package rows20250325_f941fc61-f7a3-4e4a-ab7c-87c1667fa05b.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
RuxienceRITUXIMAB-PVVRPfizer Laboratories Div Pfizer Incf941fc61-f7a3-4e4a-ab7c-87c1667fa05b2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761103
ndc (product): 0069-0249

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761103Ruxiencerituximab-pvvr351(k) BiosimilarRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2273512riTUXimab-pvvr 100 MG in 10 ML InjectionPSNf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
2273520riTUXimab-pvvr 500 MG in 50 ML InjectionPSNf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
2273517Ruxience 100 MG in 10 ML InjectionPSNf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
2273521Ruxience 500 MG in 50 ML InjectionPSNf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
227351710 ML rituximab-pvvr 10 MG/ML Injection [Ruxience]SBDf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
227352150 ML rituximab-pvvr 10 MG/ML Injection [Ruxience]SBDf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
227351210 ML rituximab-pvvr 10 MG/ML InjectionSCDf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
227352050 ML rituximab-pvvr 10 MG/ML InjectionSCDf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
227351710 ML Ruxience 10 MG/ML InjectionSYf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
227352150 ML Ruxience 10 MG/ML InjectionSYf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
2273512rituximab-pvvr 100 MG per 10 ML InjectionSYf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
2273520rituximab-pvvr 500 MG per 50 ML InjectionSYf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
2273517Ruxience 100 MG per 10 ML InjectionSYf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11
2273521Ruxience 500 MG per 50 ML InjectionSYf941fc61-f7a3-4e4a-ab7c-87c1667fa05b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0249-01000690249011 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USE2020-01-230000-00-00NoNoCurrent