FDA.reportPublic FDA data

Gazyva

Product NDC
50242-070
11-digit product format
502420070
Labeler code
50242
Product ID
50242-070_1149a53c-b5e5-4d27-8c3e-1dabee201e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
obinutuzumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA125486
Marketing category
BLA
Marketing start
2013-11-01
Substance
OBINUTUZUMAB
Active strength
1000 mg/40mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50242-07050242-070-86DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OBINUTUZUMAB1000 mg/40mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de75ec12-37b7-4fae-9b84-cafcfe64b2e8Product name120151014
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-070-01Gazyva40 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE4022
50242-070-01Gazyva1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE122
50242-070-86Gazyva40 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE4022
50242-070-86Gazyva1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-070-01ML - Milliliter50242-0701cea55db-6dcf-42e2-8138-c82199d4e73f12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OBINUTUZUMABACTIVE INGREDIENTO43472U9X8GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]7
OBINUTUZUMABACTIVE MOIETYO43472U9X8GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]7
HISTIDINEINACTIVE INGREDIENT4QD397987EGAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]7
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEINACTIVE INGREDIENTX573657P6PGAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]7
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGGAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]7
TREHALOSE DIHYDRATEINACTIVE INGREDIENT7YIN7J07X4GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RGAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-070GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.]19Current NDC, Legacy NDC, 4 package rows20230825_df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125486Gazyvaobinutuzumab351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442698Gazyva 1000 MG in 40 ML InjectionPSNdf12ceb2-5b4b-4ab5-a317-2a36bf2a3cda22
1442693obinutuzumab 1000 MG in 40 ML InjectionPSNdf12ceb2-5b4b-4ab5-a317-2a36bf2a3cda22
144269840 ML obinutuzumab 25 MG/ML Injection [Gazyva]SBDdf12ceb2-5b4b-4ab5-a317-2a36bf2a3cda22
144269340 ML obinutuzumab 25 MG/ML InjectionSCDdf12ceb2-5b4b-4ab5-a317-2a36bf2a3cda22
1442698Gazyva 1000 MG per 40 ML InjectionSYdf12ceb2-5b4b-4ab5-a317-2a36bf2a3cda22
1442693obinutuzumab 1000 MG per 40 ML InjectionSYdf12ceb2-5b4b-4ab5-a317-2a36bf2a3cda22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-070-01502420070011 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) / 40 mL in 1 VIAL, SINGLE-USE2013-11-010000-00-00NoNoCurrent
50242-070-86502420070861 VIAL, SINGLE-USE in 1 CARTON (50242-070-86) > 40 mL in 1 VIAL, SINGLE-USE2013-11-040000-00-00YesNoCurrent