Plasma derivative · BLA
GAMMAGARD Liquid ERC (Immune globulin infusion (human)) NDC 0944-2705
Human immunoglobulin g 100 mg/mL · Injection, Solution · Intravenous, Subcutaneous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0944-2705-10 | 0094427051000944270510 | 1 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01)Marketed from Jul 14, 2025 | |
| 0944-2705-50 | 0094427055000944270550 | 1 VIAL, GLASS in 1 CARTON (0944-2705-50) / 50 mL in 1 VIAL, GLASS (0944-2705-05)Marketed from Jul 14, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- GAMMAGARD Liquid ERC
- Generic name (nonproprietary)
- immune globulin infusion (human)
- Active ingredients
- Human immunoglobulin g — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 0944
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125105
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 0944-2705_2332ff1f-1311-4aaa-9d76-9a011b3f7956SPL ID 2332ff1f-1311-4aaa-9d76-9a011b3f7956
- Pharmacologic class
- Human Immunoglobulin G
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400944270510followed by a unit qualifier and the quantityPackage 00944-2705-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0944-2705
- What is NDC 0944-2705?
- 0944-2705 is the product NDC for GAMMAGARD Liquid ERC (immune globulin infusion (human)), Human immunoglobulin g 100 mg/mL injection, solution, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- GAMMAGARD Liquid ERC (Immune Globulin Infusion (Human)).
- What is the active ingredient?
- Human immunoglobulin g.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 0944. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for GAMMAGARD Liquid ERC?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under BLA 125105
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| GAMMAGARD Liquidimmune globulin infusion (human) | Human immunoglobulin g 100 mg/mL | Injection, SolutionIntravenous, Subcutaneous | Takeda Pharmaceuticals America, Inc. | 0944-2700 |