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 NDC11-digit (billing)PackageCopy
50090-6705-050090670500500906705001 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 SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761059
Marketing start
Listing expires
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

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 . 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)

About NDC 50090-6705

What is NDC 50090-6705?
50090-6705 is the product NDC for Hadlima (adalimumab-bwwd), Adalimumab 40 mg/.8mL solution, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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.

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

Other Hadlima NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousA-S Medication Solutions50090-670650090-6706-00
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousA-S Medication Solutions50090-670750090-6707-00
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-18378206-0183-01
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-18478206-0184-01
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-18578206-0185-01
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousOrganon LLC78206-18678206-0186-01
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousOrganon LLC78206-18778206-0187-0178206-0187-59

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
ProductStrengthForm · routeLabelerProduct NDC
Adalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousCordavis Limited83457-186
Adalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousCordavis Limited83457-187
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousA-S Medication Solutions50090-6706
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousA-S Medication Solutions50090-6707
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-183
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-184
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-185
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousOrganon LLC78206-186
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousOrganon LLC78206-187

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