NDC codes

FDA NDC Directory
Product NDC (as listed)82829-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82829-0002Add 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
82829-002-0182829000201828290002011 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 19, 2023
82829-002-9982829000299828290002991 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 19, 2023 · Sample package

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)
Izervay
Generic name (nonproprietary)
avacincaptad pegol
Active ingredients
Avacincaptad pegol sodium — 20 mg/mL
Dosage form
Injection
Route
Intravitreal
Labeler
Astellas Pharma US, Inc.NDC labeler code 82829
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 217225
Marketing start
Listing expires
Other FDA classes
Complement Inhibitors (Mechanism)
Identifiers
Product ID 82829-002_7eb1c0ad-51ef-4edd-9f71-558f4e53b07cSPL ID 7eb1c0ad-51ef-4edd-9f71-558f4e53b07c
Pharmacologic class
Complement Inhibitor

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.

NDC on a medical claim

N482829000201 followed by a unit qualifier and the quantity

Package 82829-0002-01. 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 82829-002

What is NDC 82829-002?
82829-002 is the product NDC for Izervay (avacincaptad pegol), Avacincaptad pegol sodium 20 mg/mL injection, listed with the FDA by Astellas Pharma US, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Izervay (Avacincaptad pegol).
What is the active ingredient?
Avacincaptad pegol sodium.
Who is the labeler?
Astellas Pharma US, Inc., NDC labeler code 82829. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Izervay?
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.

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