Plasma derivative · BLA
Xembify (Immune globulin subcutaneous, human-klhw) NDC 13533-810
Human immunoglobulin g 200 mg/mL · Solution · Subcutaneous · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13533-810-05 | 1353308100513533081005 | 1 VIAL in 1 CARTON (13533-810-05) / 5 mL in 1 VIAL (13533-810-06)Marketed from Jul 3, 2019 | |
| 13533-810-10 | 1353308101013533081010 | 1 VIAL in 1 CARTON (13533-810-10) / 10 mL in 1 VIAL (13533-810-11)Marketed from Jul 3, 2019 | |
| 13533-810-20 | 1353308102013533081020 | 1 VIAL in 1 CARTON (13533-810-20) / 20 mL in 1 VIAL (13533-810-21)Marketed from Jul 3, 2019 | |
| 13533-810-50 | 1353308105013533081050 | 1 VIAL in 1 CARTON (13533-810-50) / 50 mL in 1 VIAL (13533-810-51)Marketed from Jul 3, 2019 |
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)
- Xembify
- Generic name (nonproprietary)
- immune globulin subcutaneous, human-klhw
- Active ingredients
- Human immunoglobulin g — 200 mg/mL
- Dosage form
- Solution
- Route
- Subcutaneous
- Labeler
- GRIFOLS USA, LLCNDC labeler code 13533
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125683
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 13533-810_3d491d8b-7fa0-47e4-bec0-4fe6d944fa25SPL ID 3d491d8b-7fa0-47e4-bec0-4fe6d944fa25
- 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
N413533081005followed by a unit qualifier and the quantityPackage 13533-0810-05. 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 13533-810
- What is NDC 13533-810?
- 13533-810 is the product NDC for Xembify, Human immunoglobulin g 200 mg/mL solution, listed with the FDA by GRIFOLS USA, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xembify (Immune globulin subcutaneous, human-klhw).
- 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 Xembify?
- 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.