Hadlima (adalimumab-bwwd) NDC 50090-6705

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-6705Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-6705Add 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
50090-6705-0	50090670500	1 SYRINGE in 1 CARTON (50090-6705-0) / .8 mL in 1 SYRINGEMarketed from Sep 27, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Hadlima
Generic name (nonproprietary): adalimumab-bwwd
Active ingredients: Adalimumab — 40 mg/.8mL
Dosage form: Solution
Route: Subcutaneous
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761059
Marketing start: Jul 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Monoclonal (Chemical structure)Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers: Product ID 50090-6705_f29c7432-aeb1-4eea-b6b1-05572b973220SPL ID f29c7432-aeb1-4eea-b6b1-05572b973220SPL set ID 7345f276-102e-4175-b7ef-ff1706b05472RxCUI 2640302, 2640305UNII FYS6T7F842
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

N450090670500 followed by a unit qualifier and the quantity

Package 50090-6705-00. 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 Oct 23, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

HADLIMA is a tumor necrosis factor (TNF) blocker indicated for • Rheumatoid Arthritis (RA) ( 1.1 ): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. • Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. • Psoriatic Arthritis (PsA) ( 1.3 ) : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. • Ankylosing Spondylitis (AS) ( 1.4 ): reducing sign…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761059

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

FDA NDC Directory listings under BLA 761059
Product	Strength	Form · route	Labeler	Product NDC
Hadlimaadalimumab-bwwd	Adalimumab 40 mg/.8mL	SolutionSubcutaneous	A-S Medication Solutions	50090-6706
Hadlimaadalimumab-bwwd	Adalimumab 40 mg/.4mL	SolutionSubcutaneous	A-S Medication Solutions	50090-6707
Hadlimaadalimumab-bwwd	Adalimumab 40 mg/.8mL	SolutionSubcutaneous	Organon LLC	78206-185
Hadlimaadalimumab-bwwd	Adalimumab 40 mg/.8mL	SolutionSubcutaneous	Organon LLC	78206-183
Hadlimaadalimumab-bwwd	Adalimumab 40 mg/.8mL	SolutionSubcutaneous	Organon LLC	78206-184
Hadlimaadalimumab-bwwd	Adalimumab 40 mg/.4mL	SolutionSubcutaneous	Organon LLC	78206-186
Hadlimaadalimumab-bwwd	Adalimumab 40 mg/.4mL	SolutionSubcutaneous	Organon LLC	78206-187
Adalimumab-bwwd	Adalimumab 40 mg/.4mL	SolutionSubcutaneous	Cordavis Limited	83457-187
Adalimumab-bwwd	Adalimumab 40 mg/.4mL	SolutionSubcutaneous	Cordavis Limited	83457-186