FDA.reportPublic FDA data

KESIMPTA

Product NDC
0078-1007
11-digit product format
000781007
Labeler code
0078
Product ID
0078-1007_ab75831e-d802-456a-bae6-7c85ef8dc3ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofatumumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
BLA125326
Marketing category
BLA
Marketing start
2009-10-26
Substance
OFATUMUMAB
Active strength
20 mg/.4mL
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
KESIMPTA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFATUMUMAB20 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M95KG522R0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2390949Internal RxNorm lookup
2390954Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a8a3f53-2062-48ff-9dbe-b939df133ca3Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1007-68KESIMPTA1 in 1 CARTONINJECTION, SOLUTION111
0078-1007-68KESIMPTA0.4 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.411
0078-1007-98KESIMPTA1 in 1 CARTONINJECTION, SOLUTION111
0078-1007-98KESIMPTA0.4 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1007-68ML - Milliliter0078-1007e5b482b8-48d9-4ee9-b2fe-1e7a1172d72e12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1007KESIMPTA (OFATUMUMAB) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]8Current NDC, Legacy NDC, 4 package rows20240418_6a8a3f53-2062-48ff-9dbe-b939df133ca3.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
ndc (product): 0078-1007

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2390954KESIMPTA 20 MG in 0.4 ML Pen InjectorPSN6a8a3f53-2062-48ff-9dbe-b939df133ca311
2390949ofatumumab 20 MG in 0.4 ML Pen InjectorPSN6a8a3f53-2062-48ff-9dbe-b939df133ca311
23909540.4 ML ofatumumab 50 MG/ML Pen Injector [Kesimpta]SBD6a8a3f53-2062-48ff-9dbe-b939df133ca311
23909490.4 ML ofatumumab 50 MG/ML Pen InjectorSCD6a8a3f53-2062-48ff-9dbe-b939df133ca311
23909540.4 ML Kesimpta 50 MG/ML Pen InjectorSY6a8a3f53-2062-48ff-9dbe-b939df133ca311
2390954KESIMPTA 20 MG per 0.4 ML Sensoready Pen InjectorSY6a8a3f53-2062-48ff-9dbe-b939df133ca311
2390949ofatumumab 20 MG per 0.4 ML Pen InjectorSY6a8a3f53-2062-48ff-9dbe-b939df133ca311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-1007-68000781007681 SYRINGE, GLASS in 1 CARTON (0078-1007-68) / .4 mL in 1 SYRINGE, GLASS2020-08-200000-00-00NoNoCurrent
0078-1007-98000781007981 SYRINGE, GLASS in 1 CARTON (0078-1007-98) / .4 mL in 1 SYRINGE, GLASS2020-08-200000-00-00YesNoCurrent