NDC codes

FDA NDC Directory
Product NDC (as listed)0944-2705Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00944-2705Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0944-2705-1000944270510009442705101 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01)Marketed from Jul 14, 2025
0944-2705-5000944270550009442705501 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.

How CPT relates to drug billing

NDC on a medical claim

N400944270510 followed by a unit qualifier and the quantity

Package 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.

FDA NDC Directory listings under BLA 125105
ProductStrengthForm · routeLabelerProduct NDC
GAMMAGARD Liquidimmune globulin infusion (human)Human immunoglobulin g 100 mg/mLInjection, SolutionIntravenous, SubcutaneousTakeda Pharmaceuticals America, Inc.0944-2700

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