NDC codes

FDA NDC Directory
Product NDC (as listed)44206-456Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44206-0456Add 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
44206-456-2144206045621442060456211 SYRINGE in 1 CARTON (44206-456-21) / 5 mL in 1 SYRINGE (44206-456-94)Marketed from Jan 1, 2020

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)
Hizentra
Generic name (nonproprietary)
human immunoglobulin g
Active ingredients
Human immunoglobulin g — .2 g/mL
Dosage form
Liquid
Route
Subcutaneous
Labeler
CSL Behring AGNDC labeler code 44206
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125350
Marketing start
Listing expires
Other FDA classes
Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers
Product ID 44206-456_411c01a7-0ae7-45d2-8b4c-cbe99a2ba264SPL ID 411c01a7-0ae7-45d2-8b4c-cbe99a2ba264
Pharmacologic class
Human Immunoglobulin G

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

N444206045621 followed by a unit qualifier and the quantity

Package 44206-0456-21. 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 44206-456

What is NDC 44206-456?
44206-456 is the product NDC for Hizentra (human immunoglobulin g), Human immunoglobulin g .2 g/mL liquid, listed with the FDA by CSL Behring AG. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hizentra (Human immunoglobulin g).
What is the active ingredient?
Human immunoglobulin g.
Who is the labeler?
CSL Behring AG, NDC labeler code 44206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hizentra?
6 other product NDCs are listed under this name. See all Hizentra NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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

Other Hizentra NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-45744206-0457-22
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-45844206-0458-24
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-45144206-0451-01
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-45244206-0452-02
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-45444206-0454-04
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-45544206-0455-1044206-0455-25

Other NDCs under BLA 125350

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

FDA NDC Directory listings under BLA 125350
ProductStrengthForm · routeLabelerProduct NDC
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-451
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-452
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-454
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-455
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-457
Hizentrahuman immunoglobulin gHuman immunoglobulin g .2 g/mLLiquidSubcutaneousCSL Behring AG44206-458

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