Hadlima (Adalimumab-bwwd) NDC 78206-185

Product information

Brand name (proprietary)

Hadlima

Generic name (nonproprietary)

adalimumab-bwwd

Active ingredients

Adalimumab — 40 mg/.8mL

Dosage form

Solution

Route

Subcutaneous

Labeler

Organon LLCNDC labeler code 78206

Product type

Prescription drug

Marketing category

BLA — Biologics License ApplicationApplication BLA 761059

Marketing start

Jul 1, 2023

Listing expires

Dec 31, 2027

Other FDA classes

Monoclonal (Chemical structure)Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)

Identifiers

Product ID 78206-185_28a18c27-7052-4b4d-af4e-d81048f424e8SPL ID 28a18c27-7052-4b4d-af4e-d81048f424e8

Pharmacologic class

Tumor Necrosis Factor Blocker

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 codeMed-Code curated

J0135 — Injection, adalimumab, 20 mg

Billing unit: 20 mg. Units on the claim = dose given ÷ 20 mg.

Adalimumab is usually self-administered and dispensed through a pharmacy benefit. Adalimumab biosimilars are listed under their own names.

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

N478206018501 followed by a unit qualifier and the quantity Copy

Package 78206-0185-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 78206-185

What is NDC 78206-185?

78206-185 is the product NDC for Hadlima (adalimumab-bwwd), Adalimumab 40 mg/.8mL solution, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Hadlima (Adalimumab-bwwd).

What is the active ingredient?

Adalimumab.

Who is the labeler?

Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hadlima?

7 other product NDCs are listed under this name. See all Hadlima NDCs.

Is there a related HCPCS / J-code?

Yes: J0135, Injection, adalimumab, 20 mg. See Billing references above.

Related NDCs: other Hadlima products

Other finished products listed under the same name: strengths, forms and labelers.

Other NDCs under BLA 761059

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.