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Hizentra HUMAN IMMUNOGLOBULIN G .2 g/mL Liquid — NDC 44206-0457-22 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hizentra HUMAN IMMUNOGLOBULIN G .2 g/mL Liquid — NDC 44206-457-22 (Billing 44206-0457-22)

by CSL Behring AG · 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE

This is a package of Hizentra HUMAN IMMUNOGLOBULIN G .2 g/mL Liquid from CSL Behring AG, marketed since Jan 2020 and currently FDA-listed. It is this product's only package size.

NDC 44206-0457-22
🏷️ FDA NDC (as labeled) 44206-457-22 billing pads the product segment with a zero
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 44206-457-22 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
44206 labeler · 457 product · 22 package
Package marketed since
Jan 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4420645722 1
Medicaid fills, this package
7,609 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44206-457-22
Product NDC 44206-457
11-digit billing NDC 44206045722
NCPDP billing unit ML — per mL (volume)
Application # BLA125350
SPL Set ID 411c01a7-0ae7-45d2-8b4c-cbe99a2ba264
Established class (EPC) Human Immunoglobulin G
Mechanism of action Antigen Neutralization
Physiologic effect Passively Acquired Immunity
Chemical class Immunoglobulins
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-01
Route SUBCUTANEOUS
Dosage form LIQUID
Substance HUMAN IMMUNOGLOBULIN G
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 1910002020E530
GPI class Hizentra
GCN Seq No 078374
GCN 44686
HICL code 041798
Ingredient (HICL) Immun Glob G(Igg)/Pro/Iga 0-50
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7K
Therapeutic class — specific (HIC3) Antisera
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name HIZENTRA 2 GRAM/10 ML SYRINGE
FDB brand name Hizentra
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078374
  • GCN: 44686
  • GPI-14 (Medi-Span): 1910002020E530
  • HICL (First Databank): 041798
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 44206-457-22 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 44206-0457-22. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name HIZENTRA 2 GRAM/10 ML SYRINGE Ingredient Immun Glob G(Igg)/Pro/Iga 0-50
📗 Our plain-language guide HelloPharmacist
  • Think of it as a collection of protective proteins — called antibodies — that healthy donors have built up against many different germs. If your immune system can't make enough of...
  • What exactly is human immunoglobulin G and why do I need it?
  • It depends on the specific product your doctor prescribed. The IV versions — like Privigen, Asceniv, Qivigy, and Gammaplex — are infused into a vein, usually every 3 to 4 weeks. Hi...
  • How is it given, and how often will I need infusions?
📖 Read our full Human Immunoglobulin G guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $379.84 $3,798.44 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1559 $14.883 / J1559 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)44206-457-22
11-digit billing NDC44206-0457-22
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1559
DescriptorINJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG
Billing units / pkg2 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 100 MG, so one package = 2 billing units.
Medicare Part B spend (2026 (Q1))$79,429,302 · 13,119 claims · $6,054.52 per claim (all NDCs under J1559)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44206-0457-22 You're viewing this Main listing 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE 2020-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hizentra .2 g/mL 44206-0451-01 CSL 1 vial — — FDA listed —
Hizentra .2 g/mL 44206-0452-02 CSL 1 vial — — FDA listed —
Hizentra .2 g/mL 44206-0454-04 CSL 1 vial — — FDA listed —
Hizentra .2 g/mL 44206-0455-10 CSL 1 vial — — FDA listed —
Hizentra .2 g/mL 44206-0456-21 CSL 1 syringe — — FDA listed —
Hizentra .2 g/mLthis 44206-0457-22 CSL 1 syringe — — FDA listed —
Hizentra .2 g/mL 44206-0458-24 CSL 1 syringe — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2010
First FDA approval
Mar 2010
📍
2026
Currently FDA-listed
16 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Human Immunoglobulin G inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 741C1PWQ88
    Human immunoglobulin A is an antibody protein naturally found in the human body. In medicines, it's used as an active therapeutic component to help the immune system fight infections and disease, rather than as a typical inactive filler or binder.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 9DLQ4CIU6V
    Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCSL Behring AG
FDA applicationBLA125350 (BLA)
Labeler code44206
First marketedJan 2020
Product typePlasma Derivative
Portfolio14 products on file

More NDCs from CSL Behring AG labeler code 44206

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7.6K
Units reimbursed last 4 qtrs
35.2K
Gross reimbursed last 4 qtrs
$13.39M
Avg / prescription
$1,759.20
Avg / unit
$379.85
Latest quarter Q1 2026
1.8KRx
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 2,521 Rx Managed care · 5,088 Rx
State Medicaid map
Alaska: no data reported AK Maine: 251 units · 18.0 per 100k residents ME Washington: 714 units · 9.1 per 100k residents WA Idaho: no data reported ID Montana: 101 units · 8.9 per 100k residents MT North Dakota: no data reported ND Minnesota: 283 units · 4.9 per 100k residents MN Wisconsin: 1,073 units · 18.2 per 100k residents WI Michigan: 301 units · 3.0 per 100k residents MI New York: 2,321 units · 11.9 per 100k residents NY Vermont: no data reported VT New Hampshire: 50 units · 3.6 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 283 units · 8.8 per 100k residents IA Illinois: 2,072 units · 16.5 per 100k residents IL Indiana: 1,081 units · 15.8 per 100k residents IN Ohio: 1,189 units · 10.1 per 100k residents OH Pennsylvania: 2,300 units · 17.7 per 100k residents PA New Jersey: 536 units · 5.8 per 100k residents NJ Massachusetts: 2,040 units · 29.1 per 100k residents MA California: 4,388 units · 11.3 per 100k residents CA Utah: 31 units · 0.9 per 100k residents UT Colorado: 1,588 units · 27.0 per 100k residents CO Nebraska: 847 units · 42.8 per 100k residents NE Missouri: 1,002 units · 16.2 per 100k residents MO Kentucky: 328 units · 7.2 per 100k residents KY West Virginia: 223 units · 12.6 per 100k residents WV Virginia: 345 units · 4.0 per 100k residents VA Maryland: 48 units · 0.8 per 100k residents MD Connecticut: 68 units · 1.9 per 100k residents CT Rhode Island: 58 units · 5.3 per 100k residents RI Arizona: 439 units · 5.9 per 100k residents AZ New Mexico: no data reported NM Kansas: 381 units · 13.0 per 100k residents KS Arkansas: 140 units · 4.6 per 100k residents AR Tennessee: 222 units · 3.1 per 100k residents TN North Carolina: 2,491 units · 23.0 per 100k residents NC South Carolina: 527 units · 9.8 per 100k residents SC Delaware: no data reported DE Oklahoma: 124 units · 3.1 per 100k residents OK Louisiana: 1,361 units · 29.8 per 100k residents LA Mississippi: no data reported MS Alabama: 762 units · 14.9 per 100k residents AL Georgia: 524 units · 4.8 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,457 units · 8.1 per 100k residents TX Florida: 2,295 units · 10.2 per 100k residents FL
Units reimbursed · per 100k residents
0.842.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nebraska 42.8 /100k
2 Louisiana 29.8 /100k
3 Massachusetts 29.1 /100k
4 Colorado 27.0 /100k
5 North Carolina 23.0 /100k
6 Wisconsin 18.2 /100k
7 Maine 18.0 /100k
8 Pennsylvania 17.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Hizentra — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hizentra. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$63.89M
Claims incl. refills
7.2K
Beneficiaries
1.7K
Spend / beneficiary
$36,845.21
Spend / claim
$8,835.51
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for HUMAN IMMUNOGLOBULIN G — the ingredient across all brands.

Top reported reactions

Fatigue2,479
Headache2,287
Covid-192,170
Pneumonia1,902
Sinusitis1,893
Nausea1,603
Malaise1,521

Reporter sex

20,512 reports

Serious outcomes

Hospitalization7,788
Death2,741
Life-threatening1,194
Disabling229
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,197 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CSL Behring AG. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CSL Behring AG is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1559 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 44206-0456-21 · CSL 44206-0458-24 · CSL →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.