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Gamunex-C Immune Globulin (Human) 10 g/100mL Injection — NDC 13533-800-40 (Billing 13533-0800-40)

by GRIFOLS USA, LLC · 1 VIAL, GLASS in 1 CARTON / 400 mL in 1 VIAL, GLASS

This is a package of Gamunex-C Immune Globulin (Human) 10 g/100mL Injection from GRIFOLS USA, LLC, marketed since Oct 2010 and currently FDA-listed.

NDC 13533-0800-40
🏷️ FDA NDC (as labeled) 13533-800-40 billing pads the product segment with a zero
This package
Contains400 mL in 1 vial, glass Medicaid pays$10.92 / unit · 12 mo Per package$10.92 / 1 vial · Medicaid Pack sizes6 compare ↓
Product page 13533-0800-24 Also comes in: 10 mL 13533-800-12 25 mL 13533-800-15 50 mL 13533-800-20 200 mL 13533-800-24 100 mL 13533-800-71
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 13533-800-40 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
13533 labeler · 800 product · 40 package
Package marketed since
Oct 13, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1353380040 6
Medicaid fills, this package
3,434 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) 13533-800-40
Product NDC 13533-800
11-digit billing NDC 13533080040
NCPDP billing unit ML — per mL (volume)
Application # BLA125046
SPL Set ID 8d03bd99-9ea6-4e20-b103-6a0a1fbcdce2
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 2010-10-13
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION
Substance HUMAN IMMUNOGLOBULIN G
Biologic (Purple Book) 351(a)

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

GPI-14 19100020302060
GPI class Gamunex-C
GCN Seq No 073008
GCN 37322
HICL code 043712
Ingredient (HICL) Immune Globul G/Gly/Iga Avg 46
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 GAMUNEX-C 40 GRAM/400 ML VIAL
FDB brand name Gamunex-C
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073008
  • GCN: 37322
  • GPI-14 (Medi-Span): 19100020302060
  • HICL (First Databank): 043712
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 13533-800-40 — 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 → 13533-0800-40. 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 GAMUNEX-C 40 GRAM/400 ML VIAL Ingredient Immune Globul G/Gly/Iga Avg 46
📗 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $10.92 $10.92 / 1 vial
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1561 $49.014 / J1561 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)13533-800-40
11-digit billing NDC13533-0800-40
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1561
DescriptorINJECTION, IMMUNE GLOBULIN, (GAMUNEX-C/GAMMAKED), NON-LYOPHILIZED (E. G. LIQUID), 500 MG
Billing units / pkg0.2 units
How the units are derivedThis package is 400 ML; the HCPCS unit is 500 MG, so one package = 0.2 billing units.
Medicare Part B spend (2026 (Q1))$164,005,321 · 40,877 claims · $4,012.17 per claim (all NDCs under J1561)
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
13533-0800-12 13533-800-12 1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS 2010-10-13 — Active
13533-0800-15 13533-800-15 1 VIAL, GLASS in 1 CARTON / 25 mL in 1 VIAL, GLASS 2010-10-13 — Active
13533-0800-20 13533-800-20 1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS 2010-10-13 — Active
13533-0800-24 13533-800-24 Main listing 1 VIAL, GLASS in 1 CARTON / 200 mL in 1 VIAL, GLASS 2010-10-13 — Active
13533-0800-40 You're viewing this 1 VIAL, GLASS in 1 CARTON / 400 mL in 1 VIAL, GLASS 2010-10-13 — Active
13533-0800-71 13533-800-71 1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS 2010-10-13 — Active

This pack accounts for about 13% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, glass in 1 carton / 400 ml in 1 vial, glass.
What NDC number is used to bill for this package of Gamunex-C Immune Globulin (Human) 10 g/100mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gamunex-C 10 g/100mLthis 13533-0800-40 GRIFOLS 1 vial — — FDA listed —
Gammaked 10 g/100mL 76125-0900-01 KEDRION 1 vial — — 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

🏛️
2003
First FDA approval
Aug 2003
📍
2026
Currently FDA-listed
23 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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Baygam, Gamastan S/DImmune Globulin (Human)
🔒 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.
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.

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.

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

LabelerGRIFOLS USA, LLC
FDA applicationBLA125046 (BLA)
Labeler code13533
First marketedOct 2010
Product typePlasma Derivative
Portfolio52 products on file

More NDCs from GRIFOLS USA, LLC labeler code 13533

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
3.4K
Units reimbursed last 4 qtrs
2.3M
Gross reimbursed last 4 qtrs
$24.61M
Avg / prescription
$7,168.00
Avg / unit
$10.9173
Latest quarter Q1 2026
802Rx
Fee-for-service vs managed care ⓘ
32% FFS 68% MCO
Fee-for-service · 1,088 Rx Managed care · 2,346 Rx
State Medicaid map
Alaska: 4,600 units · 628 per 100k residents AK Maine: 11,950 units · 857 per 100k residents ME Washington: 24,000 units · 307 per 100k residents WA Idaho: 15,200 units · 774 per 100k residents ID Montana: 17,920 units · 1,583 per 100k residents MT North Dakota: no data reported ND Minnesota: 48,700 units · 849 per 100k residents MN Wisconsin: 45,650 units · 772 per 100k residents WI Michigan: 131,850 units · 1,314 per 100k residents MI New York: 161,855 units · 827 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 51,550 units · 1,218 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 88,225 units · 703 per 100k residents IL Indiana: 88,500 units · 1,290 per 100k residents IN Ohio: 29,480 units · 250 per 100k residents OH Pennsylvania: 47,400 units · 366 per 100k residents PA New Jersey: 165,806 units · 1,785 per 100k residents NJ Massachusetts: 139,850 units · 1,998 per 100k residents MA California: 199,600 units · 512 per 100k residents CA Utah: 4,400 units · 129 per 100k residents UT Colorado: 73,200 units · 1,245 per 100k residents CO Nebraska: no data reported NE Missouri: 69,150 units · 1,116 per 100k residents MO Kentucky: 33,200 units · 734 per 100k residents KY West Virginia: no data reported WV Virginia: 53,350 units · 612 per 100k residents VA Maryland: 35,200 units · 570 per 100k residents MD Connecticut: 14,940 units · 413 per 100k residents CT Rhode Island: no data reported RI Arizona: 162,600 units · 2,188 per 100k residents AZ New Mexico: no data reported NM Kansas: 9,200 units · 313 per 100k residents KS Arkansas: 5,600 units · 183 per 100k residents AR Tennessee: 51,300 units · 720 per 100k residents TN North Carolina: 89,050 units · 822 per 100k residents NC South Carolina: 34,000 units · 633 per 100k residents SC Delaware: 4,800 units · 466 per 100k residents DE Oklahoma: 27,485 units · 678 per 100k residents OK Louisiana: 45,660 units · 998 per 100k residents LA Mississippi: no data reported MS Alabama: 5,200 units · 102 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 113,350 units · 372 per 100k residents TX Florida: 150,855 units · 667 per 100k residents FL
Units reimbursed · per 100k residents
1022,188
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 Arizona 2,188 /100k
2 Massachusetts 1,998 /100k
3 New Jersey 1,785 /100k
4 Montana 1,583 /100k
5 Michigan 1,314 /100k
6 Indiana 1,290 /100k
7 Colorado 1,245 /100k
8 Oregon 1,218 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial13533-0800-71 7,664 Rx · $31,748,329
1 vial13533-0800-24 7,650 Rx · $38,310,319
1 vial13533-0800-20 5,437 Rx · $14,974,312
1 vial this page13533-0800-40 3,434 Rx · $24,614,924
1 vial13533-0800-12 1,182 Rx · $1,772,656
1 vial13533-0800-15 135 Rx · $112,752
Drug total (last 4 qtrs): 25,502 Rx · 9,532,273 units · $111,533,293 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Gamunex-C — 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 Gamunex-C. 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
$201.83M
Claims incl. refills
24.4K
Beneficiaries
6.2K
Spend / beneficiary
$32,606.15
Spend / claim
$8,256.92
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 (Human) — the ingredient across all brands.

Top reported reactions

Expired Product Administered5
Renal Failure4
Liver Function Test Abnormal3
Multi-organ Failure3
Sepsis3
Acute Respiratory Distress Syndrome2
Acute Respiratory Failure2

Reporter sex

51 reports
Male · 58%
Female · 42%

Serious outcomes

Hospitalization17
Death8
Life-threatening4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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 — 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 — 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 GRIFOLS USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 1 vial (13533-0800-12), 1 vial (13533-0800-15), 1 vial (13533-0800-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
GRIFOLS USA, LLC 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 J1561 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.
← 13533-0706-22 · GRIFOLS 13533-0805-01 · GRIFOLS →
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.