Panzyga immune globulin intravenous (human) 100 mg/mL Solution
by Pfizer Laboratories Div Pfizer Inc · 1 BOTTLE, GLASS in 1 CARTON (0069-1011-02) / 10 mL in 1 BOTTLE, GLASS (0069-1011-01)
NDC 00069-1011-02
🏷️ FDA NDC (as labeled)
0069-1011-02
billing pads the labeler segment with a zero
Brand
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
0069-1011-02
Product NDC
0069-1011
11-digit billing NDC
00069101102
NCPDP billing unit
ML — per mL (volume)
Application #
BLA125587
SPL Set ID
e2cc5ddf-119e-ade3-79c2-c712cfbee099
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
2019-08-09
Route
INTRAVENOUS
Dosage form
SOLUTION
Substance
HUMAN IMMUNOGLOBULIN G
GPI-14
19100020602020
GPI class
Panzyga
GCN Seq No
079125
GCN
45566
HICL code
045354
Ingredient (HICL)
Immun Glob G(Igg)-Ifas/Glycine
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
PANZYGA 10% (1 G/10 ML) VIAL
FDB brand name
Panzyga
Legend status
F — Federal legend — prescription drug or device
Biologic (Purple Book)
351(a)
Why two NDCs?
The FDA registers this code as 0069-1011-02 — a 4-4-2 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 labeler segment → 00069-1011-02. 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.
🏭 Manufacturer & labeler
LabelerPfizer Laboratories Div Pfizer Inc
FDA applicationBLA125587 (BLA)
Labeler code00069
First marketedAug 2019
Product typePlasma Derivative
Portfolio242 products on file
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.
🩺 Clinical
Label name PANZYGA 10% (1 G/10 ML) VIAL Ingredient Immun Glob G(Igg)-Ifas/Glycine
📗 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about immune globulin intravenous (human)?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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.
💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1576 | $71.346 / J1576 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)0069-1011-02
11-digit billing NDC00069-1011-02
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1576
DescriptorINJECTION, IMMUNE GLOBULIN (PANZYGA), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG
Billing units / pkg0.2 units
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Panzyga 100 mg/mL 00069-1415-02 | Pfizer | 1 bottle | — | — | FDA listed | — |
| Panzyga 100 mg/mL 00069-1109-02 | Pfizer | 1 bottle | — | — | FDA listed | — |
| Panzyga 100 mg/mL 00069-1224-02 | Pfizer | 1 bottle | — | — | FDA listed | — |
| Panzyga 100 mg/mL 00069-1558-02 | Pfizer | 1 bottle | — | — | FDA listed | — |
| Panzyga 100 mg/mLthis 00069-1011-02 | Pfizer | 1 bottle | — | — | FDA listed | — |
| Panzyga 100 mg/mL 00069-1312-02 | Pfizer | 1 bottle | — | — | FDA listed | — |
| Panzyga 100 mg/mL 68982-0822-01 | Octapharma | 1 bottle | — | — | 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
🏛️
2018
First FDA approval
Aug 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2030. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
FDA Purple Book — biosimilars & interchangeables
ⓘ
Reference product
BivigamImmune Globulin Intravenous (Human)
Carimune, Carimune Nf, Panglobulin, SandoglobulinImmune Globulin Intravenous (Human)
Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)
GamimuneImmune Globulin Intravenous (Human)
Gammagard, Gammagard S/D, IveegamImmune Globulin Intravenous (Human)
GammaplexImmune Globulin Intravenous (Human)
gammar i.v.,gammar-p i.v.Immune Globulin Intravenous (Human)
OctagamImmune Globulin Intravenous (Human)
PanzygaImmune Globulin Intravenous (Human)-ifas
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2018
2020
2022
2024
2026
2028
2030
Biologic patent
Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
FDA exclusivity
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Aug 2, 2030 |
Common questions
Is there a biosimilar for PANZYGA 10% (1 G/10 ML) VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Panzyga — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Panzyga. 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
$45.87M
Claims incl. refills
2.9K
Beneficiaries
838
Spend / beneficiary
$54,733.06
Spend / claim
$15,756.20
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 Immune globulin intravenous (human) — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 41%
Female · 59%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00069-1011-02 You're viewing this | 1 BOTTLE, GLASS in 1 CARTON (0069-1011-02) / 10 mL in 1 BOTTLE, GLASS (0069-1011-01) | 2019-08-09 | Active |
🧭 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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“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 FDA registers it as 0069-1011-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00069-1011-02, written without dashes as 00069101102. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00069-1011-02, the first segment (00069) is the labeler code FDA assigned to Pfizer Laboratories Div Pfizer Inc; the middle segment (1011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Pfizer Laboratories Div Pfizer Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pfizer Laboratories Div Pfizer Inc 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 J1576 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.
📄 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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.