GAMMAKED J Code: J1561
Injection, immune globulin, (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg
Q4 2026 Medicare Payment Limit for J1561, effective October 1, 2026: $48.022 per HCPCS billing unit, down 2.0% from $49.014. From CMS's final file.
Drug & Product Overview
About GAMMAKED
Gammaked is a medication aligned to the HCPCS J Code: J1561 for billing, pricing, and reimbursement purposes in the United States. It is an Immunoglobulin drug administered via the intravenous or subcutaneous routes and manufactured by Grifols.
According to CMS Drug Use Information: This medication is used in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This medication is made from healthy human blood that has a high level of antibodies which help fight infections. Some immune globulin products are also used to increase the number of certain blood cells (platelets) in people with a certain blood disorder (idiopathic thrombocytopenic purpura-ITP). Platelets are needed to stop bleeding and to form normal blood clots. Some products may also be used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps improve these symptoms and prevent relapse.
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. Showing 5 of 12 NDCs — log in for the full crosswalk.
| NDC Code | Drug | Manufacturer | Billing Units / Pkg | Package Size |
|---|---|---|---|---|
| 13533-0800-12 | Gamunex-C | GRIFOLS USA, LLC | 2 | 10000 MG / 100 ML |
| 13533-0800-15 | Gamunex-C | GRIFOLS USA, LLC | 5 | 10000 MG / 100 ML |
| 13533-0800-20 | Gamunex-C | GRIFOLS USA, LLC | 10 | 10000 MG / 100 ML |
| 13533-0800-24 | Gamunex-C | GRIFOLS USA, LLC | 40 | 10000 MG / 100 ML |
| 76125-0900-10 | Gammaked | KEDRION BIOPHARMA, INC. | 20 | 10000 MG / 100 ML |
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GAMMAKED Pricing & Reimbursement
National median reimbursement across major commercial payers.
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Login to use the calculator →GAMMAKED 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) |
| 96369 Login for More | Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); initial, up to 1 hour, including pump set-up and establishment of subcutaneous infusion site(s) Login for More |
| 96370 Login for More | Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure) Login for More |
CMS has identified Gammaked (J1561) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. Wastage billing guide →
GAMMAKED Medically Unlikely Edits (MUE)
The most billing units of J1561 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 →
GAMMAKED 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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