GAMMAGARD S-D J Code: J1566
Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg
Q4 2026 Medicare Payment Limit for J1566, effective October 1, 2026: $82.756 per HCPCS billing unit, up 2.2% from $80.961. From CMS's final file.
Drug & Product Overview
About GAMMAGARD S-D
Gammagard S-D is a medication aligned to the HCPCS J Code: J1566 for billing, pricing, and reimbursement purposes in the United States. This Immunoglobulin medication is administered via the intravenous route and manufactured by Takeda Pharmaceuticals.
According to CMS Drug Use Information: This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. It is also used to increase the blood count (platelets) in persons with a certain blood disorder (idiopathic thrombocytopenia purpura-ITP). Platelets are needed to stop bleeding and form blood clots. Some immune globulin products may also be used to treat certain types of muscle weakness problem (multifocal motor neuropathy, dermatomyositis) or a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). Some products may also be used to prevent certain blood vessel disorders in people with Kawasaki syndrome.
Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.
NDC Code Information
Based on publicly available CMS files. The list of NDCs below is not exhaustive.
| NDC Code | Drug | Manufacturer | Billing Units / Pkg | Package Size |
|---|---|---|---|---|
| 00944-2656-03 | Gammagard S/D | Takeda Pharmaceuticals America, Inc. | 10 | Kit |
| 00944-2658-04 | Gammagard S/D | Takeda Pharmaceuticals America, Inc. | 20 | Kit |
GAMMAGARD S-D Pricing & Reimbursement
National median reimbursement across major commercial payers.
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Login to use the calculator →Immune Globulin 505(b)(2) Information:
| HCPCS Code | Manufacturer | Active Ingredient | HCPCS Description |
|---|---|---|---|
| J1552 | GC Biopharma | Immune Globulin | Injection, immune globulin (alyglo), 500 mg |
| J1566 | Takeda Pharmaceuticals | Immune Globulin | Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg |
| J1576 | Generic Code (Multiple Manufacturers) | Immune Globulin | Injection, immune globulin (panzyga), intravenous, non-lyophilized (e.g., liquid), 500 mg |
GAMMAGARD S-D CPT Administration Codes
The below list of CPT codes is intended for informational purposes only and may not be exhaustive. CPT® codes and descriptions are copyright American Medical Association (AMA). All rights reserved.
| CPT Code | Description |
|---|---|
| 96365 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour |
| 96366 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure) |
CMS does not include Gammagard S-D (J1566) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J1566. Wastage billing guide →
GAMMAGARD S-D Medically Unlikely Edits (MUE)
The most billing units of J1566 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 500 mg.
MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →
GAMMAGARD S-D Clinical Information
Indications and drug classification.
This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.
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Frequently Asked Questions
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