Yusimry (adalimumab-aqvh) NDC 71288-816

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-816Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0816Add 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
71288-816-81	71288081681	2 SYRINGE, GLASS in 1 CARTON (71288-816-81) / .8 mL in 1 SYRINGE, GLASSMarketed from Jul 1, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Yusimry
Generic name (nonproprietary): adalimumab-aqvh
Active ingredients: Adalimumab — 40 mg/.8mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Meitheal Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761216
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 71288-816_8113b9be-047a-4ffc-bcd0-6648c3eb6781SPL ID 8113b9be-047a-4ffc-bcd0-6648c3eb6781
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

N471288081681 followed by a unit qualifier and the quantity

Package 71288-0816-81. 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.

Other NDCs under BLA 761216

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

FDA NDC Directory listings under BLA 761216
Product	Strength	Form · route	Labeler	Product NDC
Yusimryadalimumab-aqvh	Adalimumab 40 mg/.8mL	Injection, SolutionSubcutaneous	Meitheal Pharmaceuticals Inc.	71288-815
Yusimryadalimumab-aqvh	Adalimumab 40 mg/.8mL	Injection, SolutionSubcutaneous	Coherus BioSciences Inc	70114-210
Yusimryadalimumab-aqvh	Adalimumab 40 mg/.8mL	Injection, SolutionSubcutaneous	Coherus BioSciences Inc	70114-220