What is NDC 44087-3535?

44087-3535 is the product NDC for Bavencio (avelumab), Avelumab 20 mg/mL injection, solution, concentrate, listed with the FDA by EMD Serono, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

EMD Serono, Inc., NDC labeler code 44087. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bavencio?

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.

Bavencio NDC 44087-3535 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)44087-3535Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44087-3535Add 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
44087-3535-1	4408735350144087353501	1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 23, 2017

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): Bavencio
Generic name (nonproprietary): avelumab
Active ingredients: Avelumab — 20 mg/mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: EMD Serono, Inc.NDC labeler code 44087
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761049
Marketing start: Mar 23, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Monoclonal (Chemical structure)Programmed Death Ligand-1 Antagonists (Mechanism)Programmed Death Ligand-1-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 44087-3535_1c740e75-10b0-48c1-a92f-c7b76f9950c3SPL ID 1c740e75-10b0-48c1-a92f-c7b76f9950c3
Pharmacologic class: Programmed Death Ligand-1 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 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

N444087353501 followed by a unit qualifier and the quantity

Package 44087-3535-01. 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 44087-3535

What is NDC 44087-3535?: 44087-3535 is the product NDC for Bavencio (avelumab), Avelumab 20 mg/mL injection, solution, concentrate, listed with the FDA by EMD Serono, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bavencio (Avelumab).
What is the active ingredient?: Avelumab.
Who is the labeler?: EMD Serono, Inc., NDC labeler code 44087. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bavencio?: 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.

Bavencio (Avelumab) NDC 44087-3535