NDC 0069-1109-02 (00069-1109-02) — Panzyga immune globulin intravenous

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0069-1109-02

Product NDC 0069-1109

11-digit billing NDC 00069110902

NCPDP billing unit ML — per mL (volume)

Application # BLA125587

SPL Set ID fb008bad-3696-e7b9-d3f8-3718e16e19d8

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

Biologic (Purple Book) 351(a)

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

GPI-14 19100020602025

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% (2.5 G/25 ML) VIAL

FDB brand name Panzyga

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 079125
GCN: 45566
GPI-14 (Medi-Span): 19100020602025
HICL (First Databank): 045354
AHFS class code: 80:04.00.00

Why two NDCs? The FDA registers this code as 0069-1109-02 — 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 → 00069-1109-02. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 5, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

Clinical

Label name PANZYGA 10% (2.5 G/25 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?

📖 Read our full Human Immunoglobulin G guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 5, 2026

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	$13.54	$338.62 / 25 ml
Medicare drug plans payPart D · Q2 2026	$21.95	$548.65 / 25 ml
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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · through Q1 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Billing & reimbursement

FDA NDC (as labeled)0069-1109-02

11-digit billing NDC00069-1109-02

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

How the units are derivedThis package is 25 ML; the HCPCS unit is 500 MG, so one package = 0.2 billing units.

Medicare Part B spend (2026 (Q1))$23,896,606 · 3,549 claims · $6,733.34 per claim (all NDCs under J1576)

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.

CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
DMEPDAC NDC-HCPCS crosswalk
openFDA NSDE billing units · refreshed Sep 7, 2026

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
00069-1109-02 You're viewing this Main listing	1 BOTTLE, GLASS in 1 CARTON / 25 mL in 1 BOTTLE, GLASS	2019-08-09	—	Active

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/mLthis 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/mL 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Purple Book · refreshed Sep 5, 2026
CMS NADAC weekly file

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.

📅 FDA approved Aug 2, 2018 ⏳ ~3.8 yr to latest listed protection

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

Today

LOE

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% (2.5 G/25 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.

FDA Purple Book · refreshed Sep 5, 2026

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

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.

FDA label on DailyMed · label index refreshed Oct 5, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerPfizer Laboratories Div Pfizer Inc

FDA applicationBLA125587 (BLA)

Labeler code00069

First marketedAug 2019

Product typePlasma Derivative

Portfolio242 products on file

More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069

🔎 All NDCs from Pfizer Laboratories Div Pfizer Inc

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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

23

Units reimbursed last 4 qtrs

450

Gross reimbursed last 4 qtrs

$6.1K

Avg / prescription

$265.01

Avg / unit

$13.5448

Latest quarter Q1 2026

0Rx

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 23 Rx

State Medicaid map

Units reimbursed · per 100k residents

3.83.8

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 Ohio 3.8 /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 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

Urticaria103

Pruritus77

Rash55

Infusion Related Reaction45

Headache39

Nausea38

Fatigue33

Age at onset

Neonate2

Infant1

Adult46

Elderly4

Reporter sex

Serious outcomes

Hospitalization41

Death10

Disabling3

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.

FDA Adverse Event Reporting System (FAERS)

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	— Not published for this NDC No photo available yet for this listing.
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)	✓ 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 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.

Related NDC lookups

🧪 All Immune Globulin Intravenous (Human) NDCsSame ingredient 🏭 All Pfizer labeler NDCsLabeler code 00069 📚 All Human Immunoglobulin G NDCsDrug class 🧾 J1576 billing & NDC crosswalkJ-code

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Antisera.

Immun Glob G(Igg)-Hipp/Maltose 00069-1061-02 Immun Globg(Igg)/Malt/Iga Ov50 00069-6002-01 Rho(D) Immune Globulin 00562-7805-01 Igg/Hyaluronidase,Recombinant 00944-2510-02 Immun Glob G/Gly/Gluc/Iga 0-50 00944-2656-03 Immun Glob G(Igg)/Gly/Iga Ov50 00944-2700-02 Immun Glob G(Igg)/Gly/Iga 0-50 00944-2705-10 Rabies Immune Globulin/Pf 13533-0318-01 Immune Globul G (Igg)/Glycine 13533-0335-04 Tetanus Immune Globulin/Pf 13533-0634-02 Hepatitis B Immune Globulin 13533-0636-01 Immune Globul G/Gly/Iga Avg 46 13533-0800-12 Immune Globulin,Gamma(Igg)Klhw 13533-0810-05 Immun Glob G(Igg)/Pro/Iga 0-50 44206-0436-05 Cytomegalovirus Immune Globuln 44206-0532-11

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 1, 2026

Panzyga immune globulin intravenous (human) 100 mg/mL Solution — NDC 0069-1109-02 (Billing 00069-1109-02)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Clinical

Patient education

Supplement & herbal interactions

Pricing

Billing & reimbursement

Packaging — all sizes for this product

Therapeutic equivalents

Availability & biosimilar status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069

Full FDA label FDA SPL

Medicaid utilization & spend

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

Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

About this NDC listing & data coverage

Questions about this listing