What is NDC 0078-1007?

0078-1007 is the product NDC for Kesimpta (ofatumumab), Ofatumumab 20 mg/.4mL injection, solution, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Kesimpta?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Kesimpta NDC 0078-1007 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-1007Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-1007Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0078-1007-68	00078100768	1 SYRINGE, GLASS in 1 CARTON (0078-1007-68) / .4 mL in 1 SYRINGE, GLASSMarketed from Aug 20, 2020
0078-1007-98	00078100798	1 SYRINGE, GLASS in 1 CARTON (0078-1007-98) / .4 mL in 1 SYRINGE, GLASSMarketed from Aug 20, 2020 · Sample package

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Kesimpta
Generic name (nonproprietary): ofatumumab
Active ingredients: Ofatumumab — 20 mg/.4mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125326
Marketing start: Oct 26, 2009
Listing expires: Dec 31, 2027
Other FDA classes: CD20-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 0078-1007_ab75831e-d802-456a-bae6-7c85ef8dc3edSPL ID ab75831e-d802-456a-bae6-7c85ef8dc3edSPL set ID 6a8a3f53-2062-48ff-9dbe-b939df133ca3RxCUI 2390949, 2390954UNII M95KG522R0
Pharmacologic class: CD20-directed Cytolytic Antibody

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400078100768 followed by a unit qualifier and the quantity

Package 00078-1007-68. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 1, 2026.

Indications (excerpt from the label)

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. KESIMPTA is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-1007

What is NDC 0078-1007?: 0078-1007 is the product NDC for Kesimpta (ofatumumab), Ofatumumab 20 mg/.4mL injection, solution, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Kesimpta (Ofatumumab).
What is the active ingredient?: Ofatumumab.
Who is the labeler?: Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kesimpta?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Kesimpta (Ofatumumab) NDC 0078-1007