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GAMMAGARD Liquid ERC Immune Globulin Infusion (Human) 100 mg/mL Injection, Solution — NDC 00944-2705-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GAMMAGARD Liquid ERC Immune Globulin Infusion (Human) 100 mg/mL Injection, Solution — NDC 0944-2705-10 (Billing 00944-2705-10)

by Takeda Pharmaceuticals America, Inc. · 1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS

This is a package of GAMMAGARD Liquid ERC Immune Globulin Infusion (Human) 100 mg/mL Injection, Solution from Takeda Pharmaceuticals America, Inc., marketed since Jul 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00944-2705-10
🏷️ FDA NDC (as labeled) 0944-2705-10 billing pads the labeler segment with a zero
This package
Contains100 mL in 1 vial, glass Pack sizes2 compare ↓
Also priced by: Part D plans $20.76/unit — full pricing hub ↓
Main listing for product 0944-2705 · Also comes in: 50 mL 0944-2705-50
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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 0944-2705-10 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
0944 labeler · 2705 product · 10 package
Package marketed since
Jul 14, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0944270510 9
FDA record last changed
Oct 2, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0944-2705-10
Product NDC 0944-2705
11-digit billing NDC 00944270510
NCPDP billing unit ML — per mL (volume)
Application # BLA125105
SPL Set ID 1341fd31-0754-47f0-a4d6-7255056b6541
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 2025-07-14
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance HUMAN IMMUNOGLOBULIN G
Biologic (Purple Book) 351(a)

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

GCN Seq No 088006
GCN 58069
HICL code 041995
Ingredient (HICL) Immun Glob G(Igg)/Gly/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 GAMMAGARD LIQUID ERC 10G/100ML
FDB brand name Gammagard Liquid Erc
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088006
  • GCN: 58069
  • HICL (First Databank): 041995
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 0944-2705-10 — 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 → 00944-2705-10. 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 GAMMAGARD LIQUID ERC 10G/100ML Ingredient Immun Glob G(Igg)/Gly/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 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 · Q2 2026 $20.76 $2,076.40 / 100 ml
Medicare Part B allowsASP · J1569 $49.303 / J1569 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)0944-2705-10
11-digit billing NDC00944-2705-10
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1569
DescriptorINJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID), NON-LYOPHILIZED, (E.G., LIQUID), 500 MG
Billing units / pkg0.2 units
How the units are derivedThis package is 100 ML; the HCPCS unit is 500 MG, so one package = 0.2 billing units.
Medicare Part B spend (2026 (Q1))$182,705,367 · 49,707 claims · $3,675.65 per claim (all NDCs under J1569)
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
00944-2705-10 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS 2025-07-14 — Active
00944-2705-50 0944-2705-50 1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS 2025-07-14 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, glass in 1 carton / 100 ml in 1 vial, glass.
What NDC number is used to bill for this package of GAMMAGARD Liquid ERC Immune Globulin Infusion (Human) 100 mg/mL Injection, Solution?
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
GAMMAGARD Liquid ERC 100 mg/mLthis 00944-2705-10 Takeda 1 vial — — FDA listed —
GAMMAGARD Liquid 100 mg/mL 00944-2700-02 Takeda 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

🏛️
2005
First FDA approval
Apr 2005
📍
2026
Currently FDA-listed
21 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
Gammagard LiquidImmune Globulin Infusion (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.

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

  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.

1 inactive ingredient 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

LabelerTakeda Pharmaceuticals America, Inc.
FDA applicationBLA125105 (BLA)
Labeler code00944
First marketedJul 2025
Product typePlasma Derivative
Portfolio154 products on file

More NDCs from Takeda Pharmaceuticals America, Inc. labeler code 00944

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 ↗

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) — 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 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 Takeda Pharmaceuticals America, Inc.. 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 1 other package presentation of this same product, including 1 vial (00944-2705-50). 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?
Takeda Pharmaceuticals America, 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 J1569 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.
← 00944-2700-02 · Takeda 00944-2814-01 · Takeda →
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.