GAMMAGARD S/D Immune Globulin Intravenous (Human) Kit — NDC 0944-2658-04 (Billing 00944-2658-04)
by Takeda Pharmaceuticals America, Inc. · 1 KIT in 1 CARTON * 192 mL in 1 BOTTLE * 192 mL in 1 BOTTLE * 200 mL in 1 BOTTLE
This is a package of GAMMAGARD S/D Immune Globulin Intravenous (Human) Kit from Takeda Pharmaceuticals America, Inc., marketed since May 1994 and currently FDA-listed. It is this product's only package size.
NDC 00944-2658-04
🏷️ FDA NDC (as labeled)
0944-2658-04
billing pads the labeler segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 0944-2658-04 alone.
- Record
- FDA NDC Directory package listing · Plasma derivative
- Code segments
- 0944 labeler · 2658 product · 04 package
- Package marketed since
- May 10, 1994
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0944265804 7
- Medicaid fills, this package
- 665 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)
0944-2658-04
Product NDC
0944-2658
11-digit billing NDC
00944265804
NCPDP billing unit
EA — each (per item)
Application #
BLA103133
SPL Set ID
123bfa78-6fbe-41c7-8e01-c885e58c1437
DEA schedule
Non-controlled
Marketing category
BLA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1994-05-10
Dosage form
KIT
Biologic (Purple Book)
351(a)
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
19100020102130
GPI class
Gammagard S/D Less IgA
GCN Seq No
036845
GCN
07392
HICL code
041795
Ingredient (HICL)
Immun Glob G/Gly/Gluc/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 S-D 10 G (IGA<1) SOL
FDB brand name
Gammagard S-D
Legend status
F — Federal legend — prescription drug or device
Quick answers
- GSN (GCN sequence number): 036845
- GCN: 07392
- GPI-14 (Medi-Span): 19100020102130
- HICL (First Databank): 041795
- AHFS class code: 80:04.00.00
Why two NDCs?
The FDA registers this code as 0944-2658-04 — 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 → 00944-2658-04. 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name GAMMAGARD S-D 10 G (IGA<1) SOL Ingredient Immun Glob G/Gly/Gluc/Iga 0-50
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Immune Globulin Intravenous (Human)?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $192.13 | — |
| Medicare drug plans payPart D · Q2 2026 | $2,304.12 | — |
| Medicare Part B allowsASP · J1566 | $80.961 / J1566 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)0944-2658-04
11-digit billing NDC00944-2658-04
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1566
DescriptorINJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G. POWDER), NOT OTHERWISE SPECIFIED, 500 MG
Billing units / pkg20 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 500 MG, so one package = 20 billing units.
Medicare Part B spend (2026 (Q1))$11,361,827 · 2,043 claims · $5,561.34 per claim (all NDCs under J1566)
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 Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00944-2658-04 You're viewing this Main listing | 1 KIT in 1 CARTON * 192 mL in 1 BOTTLE * 192 mL in 1 BOTTLE * 200 mL in 1 BOTTLE | 1994-05-10 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Gammagard S/D 00944-2656-03 | Takeda | 1 kit | — | — | FDA listed | — |
| Gammagard S/Dthis 00944-2658-04 | Takeda | 1 kit | — | — | 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 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
🏛️
1986
First FDA approval
Feb 1986
📍
2026
Currently FDA-listed
40 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
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.
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 Oct 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 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
LabelerTakeda Pharmaceuticals America, Inc.
FDA applicationBLA103133 (BLA)
Labeler code00944
First marketedMay 1994
Product typePlasma Derivative
Portfolio154 products on file
More NDCs from Takeda Pharmaceuticals America, Inc. labeler code 00944
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2510-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2511-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2512-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2513-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2514-02
- GAMMAGARD S/D Immune Globulin Intravenous (Human) Kit NDC 0944-2656-03
- GAMMAGARD Liquid Immune Globulin Infusion (Human) 100 mg/mL Injection, Solution NDC 0944-2700-02
- GAMMAGARD Liquid ERC Immune Globulin Infusion (Human) 100 mg/mL Injection, Solution NDC 0944-2705-10
- Aralast NP Alpha-1-Proteinase Inhibitor (Human) Kit NDC 0944-2814-01
- Aralast NP Alpha-1-Proteinase Inhibitor (Human) Kit NDC 0944-2815-01
- RECOMBINATE antihemophilic factor recombinant Kit NDC 0944-2841-10
- RECOMBINATE antihemophilic factor recombinant Kit NDC 0944-2842-10
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 8, 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 ▾
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 ↗
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
665
Units reimbursed last 4 qtrs
27.8K
Gross reimbursed last 4 qtrs
$5.34M
Avg / prescription
$8,030.46
Avg / unit
$192.13
Latest quarter Q1 2026
112Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 317 Rx Managed care · 348 Rx
State Medicaid map
Units reimbursed · per 100k residents
4.338.5
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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 Gammagard S-D — 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 Gammagard S-D. 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
$2.46M
Claims incl. refills
247
Beneficiaries
81
Spend / beneficiary
$30,404.55
Spend / claim
$9,970.72
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
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.
About this NDC listing & data coverage
Kit / multi-component package
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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 Takeda Pharmaceuticals America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
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 J1566 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.
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.