FDA.reportPublic FDA data

ARZERRA

Product NDC
0078-0669
11-digit product format
000780669
Labeler code
0078
Product ID
0078-0669_56665f95-5c96-4177-b65b-17928bb90b80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofatumumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
BLA125326
Marketing category
BLA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
OFATUMUMAB
Active strength
20 mg/mL
Pharmacologic classes
CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0078-0669DDiscontinued by firm2026-08-17
excluded packagepackage0078-06690078-0669-13DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
66021fc6-fb32-4051-a4e5-0052c5f02370Product name120210312
12a0642a-dfae-4339-8e07-f1172bb8a54aProduct name120160202
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0669-13ML - Milliliter0078-06696b248ed6-541b-4bc5-add1-7b2fab20b75712016-03-04
0078-0669-61ML - Milliliter0078-06699c7f008d-1962-43bd-bf10-c49d01d9bc3a12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0669ARZERRA (OFATUMUMAB) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]10Legacy NDC20240627_77785ce3-e8df-4ca1-8f8e-6c418c6a17de.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
KESIMPTAOFATUMUMABNovartis Pharmaceuticals Corporation6a8a3f53-2062-48ff-9dbe-b939df133ca32026-04-01Warnings, Adverse reactionsExact identifier
application number: BLA125326

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125326Arzerraofatumumab351(a)Disc2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0669-13000780669133 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) > 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61) 2016-02-010000-00-00NoNoCurrent