Plasma derivative · BLA
Gamunex-C (Immune globulin (human)) NDC 13533-800
Human immunoglobulin g 10 g/100mL · Injection · Intravenous, Subcutaneous · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13533-800-12 | 1353308001213533080012 | 1 VIAL, GLASS in 1 CARTON (13533-800-12) / 10 mL in 1 VIAL, GLASS (13533-800-13)Marketed from Oct 13, 2010 | |
| 13533-800-15 | 1353308001513533080015 | 1 VIAL, GLASS in 1 CARTON (13533-800-15) / 25 mL in 1 VIAL, GLASS (13533-800-16)Marketed from Oct 13, 2010 | |
| 13533-800-20 | 1353308002013533080020 | 1 VIAL, GLASS in 1 CARTON (13533-800-20) / 50 mL in 1 VIAL, GLASS (13533-800-21)Marketed from Oct 13, 2010 | |
| 13533-800-24 | 1353308002413533080024 | 1 VIAL, GLASS in 1 CARTON (13533-800-24) / 200 mL in 1 VIAL, GLASS (13533-800-25)Marketed from Oct 13, 2010 | |
| 13533-800-40 | 1353308004013533080040 | 1 VIAL, GLASS in 1 CARTON (13533-800-40) / 400 mL in 1 VIAL, GLASS (13533-800-41)Marketed from Oct 13, 2010 | |
| 13533-800-71 | 1353308007113533080071 | 1 VIAL, GLASS in 1 CARTON (13533-800-71) / 100 mL in 1 VIAL, GLASS (13533-800-72)Marketed from Oct 13, 2010 |
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)
- Gamunex-C
- Generic name (nonproprietary)
- immune globulin (human)
- Active ingredients
- Human immunoglobulin g — 10 g/100mL
- Dosage form
- Injection
- Route
- Intravenous, Subcutaneous
- Labeler
- GRIFOLS USA, LLCNDC labeler code 13533
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125046
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 13533-800_8d03bd99-9ea6-4e20-b103-6a0a1fbcdce2SPL ID 8d03bd99-9ea6-4e20-b103-6a0a1fbcdce2
- 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
N413533080012followed by a unit qualifier and the quantityPackage 13533-0800-12. 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 13533-800
- What is NDC 13533-800?
- 13533-800 is the product NDC for Gamunex-C (immune globulin (human)), Human immunoglobulin g 10 g/100mL injection, listed with the FDA by GRIFOLS USA, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gamunex-C (Immune Globulin (Human)).
- What is the active ingredient?
- Human immunoglobulin g.
- Who is the labeler?
- GRIFOLS USA, LLC, NDC labeler code 13533. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gamunex-C?
- 1 other product NDC are listed under this name. See all Gamunex-C NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gamunex-C products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gamunex-Cimmune globulin (human) | Human immunoglobulin g 10 g/100mL | InjectionIntravenous | GRIFOLS USA, LLC | 13533-805 | 13533-0805-0113533-0805-1113533-0805-31+1 more |
Other NDCs under BLA 125046
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 |
|---|---|---|---|---|
| Gammakedimmune globulin (human) | Human immunoglobulin g 10 g/100mL | InjectionIntravenous, Subcutaneous | KEDRION BIOPHARMA, INC. | 76125-900 |
| Gamunex-Cimmune globulin (human) | Human immunoglobulin g 10 g/100mL | InjectionIntravenous | GRIFOLS USA, LLC | 13533-805 |