FDA.reportPublic FDA data

Ruxience

Product NDC
0069-0238
11-digit product format
000690238
Labeler code
0069
Product ID
0069-0238_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
100 mg/10mL
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
RITUXIMAB100 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4F4X42SYQ6
Rxcui2273512, 2273517, 2273520, 2273521

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
0069-0238-01Ruxience10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1011
0069-0238-01Ruxience1 in 1 CARTONINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0238-01ML - Milliliter0069-0238fb651042-3a2e-4bb0-a1e8-b81e37429e1912020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0238RUXIENCE (RITUXIMAB-PVVR) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]9Current NDC, Legacy NDC, 2 package rows20250325_f941fc61-f7a3-4e4a-ab7c-87c1667fa05b.zip

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
0069-0238-01000690238011 VIAL, SINGLE-USE in 1 CARTON (0069-0238-01) / 10 mL in 1 VIAL, SINGLE-USE2020-01-230000-00-00NoNoCurrent