Prescription drug · BLA
QIVIGY kthm (human immunoglobulin g) NDC 76179-010
Human immunoglobulin g 5 g/50mL · Injection, Solution · Intravenous · Kedrion S.p.A.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76179-010-02 | 76179001002 | 1 VIAL, GLASS in 1 CARTON (76179-010-02) / 50 mL in 1 VIAL, GLASS (76179-010-01)Marketed from Sep 26, 2025 | |
| 76179-010-04 | 76179001004 | 1 VIAL, GLASS in 1 CARTON (76179-010-04) / 100 mL in 1 VIAL, GLASS (76179-010-03)Marketed from Sep 26, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- QIVIGY kthmSuffix: kthm
- Generic name (nonproprietary)
- human immunoglobulin g
- Active ingredients
- Human immunoglobulin g — 5 g/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Kedrion S.p.A.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125822
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 76179-010_59a061e8-a6b0-4036-800e-1344e2d4ce97SPL ID 59a061e8-a6b0-4036-800e-1344e2d4ce97SPL set ID 6f1933e0-240f-48f4-b246-8a30e63a4160RxCUI 2726016, 2726023, 2726025, 2726026UNII 66Y330CJHS
- 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
N476179001002followed by a unit qualifier and the quantityPackage 76179-0010-02. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for treatment of adults with primary humoral immunodeficiency (PI). ( 1 )
Excerpt only. Read the full label for complete information.