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 Identifiers#

Field, Values table
FieldValues
UniiM95KG522R0
Rxcui2390949, 2390954

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

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