Plasma derivative · BLA
Hizentra (human immunoglobulin g) NDC 44206-455
Human immunoglobulin g .2 g/mL · Liquid · Subcutaneous · CSL Behring AG
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44206-455-10 | 44206045510 | 1 VIAL, SINGLE-DOSE in 1 CARTON (44206-455-10) / 50 mL in 1 VIAL, SINGLE-DOSE (44206-455-93)Marketed from Oct 3, 2011 | |
| 44206-455-25 | 44206045525 | 1 SYRINGE in 1 CARTON (44206-455-25) / 50 mL in 1 SYRINGE (44206-455-97)Marketed from Oct 3, 2011 |
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 AG
- 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 44206-455_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.
- NDC on a medical claim
N444206045510followed by a unit qualifier and the quantityPackage 44206-0455-10. 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 125350
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hizentrahuman immunoglobulin g | Human immunoglobulin g .2 g/mL | LiquidSubcutaneous | CSL Behring AG | 44206-458 |
| Hizentrahuman immunoglobulin g | Human immunoglobulin g .2 g/mL | LiquidSubcutaneous | CSL Behring AG | 44206-454 |
| Hizentrahuman immunoglobulin g | Human immunoglobulin g .2 g/mL | LiquidSubcutaneous | CSL Behring AG | 44206-451 |
| Hizentrahuman immunoglobulin g | Human immunoglobulin g .2 g/mL | LiquidSubcutaneous | CSL Behring AG | 44206-452 |
| Hizentrahuman immunoglobulin g | Human immunoglobulin g .2 g/mL | LiquidSubcutaneous | CSL Behring AG | 44206-456 |
| Hizentrahuman immunoglobulin g | Human immunoglobulin g .2 g/mL | LiquidSubcutaneous | CSL Behring AG | 44206-457 |