FDA.reportPublic FDA data

Gazyva

Product NDC
50242-070
11-digit product format
502420070
Labeler code
50242
Product ID
50242-070_47afa519-4a05-4ac2-8604-437371837128
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gazyva
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OBINUTUZUMAB1000 mg/40mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O43472U9X8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1442693Internal RxNorm lookup
1442698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df12ceb2-5b4b-4ab5-a317-2a36bf2a3cdaAvailable on FDA.report

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

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
GazyvaOBINUTUZUMABGenentech, Inc.df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125486
ndc (product): 50242-070

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125486Gazyvaobinutuzumab351(a)Rx2026-07-01

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