Plasma derivative · BLA
Cytogam (human cytomegalovirus immune globulin) NDC 49591-532
Human cytomegalovirus immune globulin 2500 mg/50mL · Liquid · Intravenous · Kamada Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49591-532-51 | 49591053251 | 1 VIAL, GLASS in 1 CARTON (49591-532-51) / 50 mL in 1 VIAL, GLASS (49591-532-50)Marketed from Jun 1, 2023 |
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)
- Cytogam
- Generic name (nonproprietary)
- human cytomegalovirus immune globulin
- Active ingredients
- Human cytomegalovirus immune globulin — 2500 mg/50mL
- Dosage form
- Liquid
- Route
- Intravenous
- Labeler
- Kamada Ltd.
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103189
- Marketing start
- Listing expires
- Other FDA classes
- Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)Virus Neutralization (Mechanism)Virus-specific Hyperimmune Globulins (EXT)
- Identifiers
- Product ID 49591-532_59d63ee0-9e77-824d-e063-6394a90ae055SPL ID 59d63ee0-9e77-824d-e063-6394a90ae055
- 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
N449591053251followed by a unit qualifier and the quantityPackage 49591-0532-51. 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.