Plasma derivative · BLA
WinRho SDF (Human rho(d) immune globulin) NDC 49591-330
Human rho(D) immune globulin 1500 [iU]/1.3mL · Injection, Solution · Intramuscular, Intravenous · Kamada Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49591-330-51 | 4959103305149591033051 | 1 VIAL, GLASS in 1 CARTON (49591-330-51) / 1.3 mL in 1 VIAL, GLASS (49591-330-11)Marketed from Aug 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)
- WinRho SDF
- Generic name (nonproprietary)
- human rho(d) immune globulin
- Active ingredients
- Human rho(D) immune globulin — 1500 [iU]/1.3mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Kamada Ltd.NDC labeler code 49591
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103649
- Marketing start
- Listing expires
- Other FDA classes
- Endogenous Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 49591-330_5dc0b426-2324-93d0-e063-6394a90aa74cSPL ID 5dc0b426-2324-93d0-e063-6394a90aa74c
- 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
N449591033051followed by a unit qualifier and the quantityPackage 49591-0330-51. 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.
About NDC 49591-330
- What is NDC 49591-330?
- 49591-330 is the product NDC for WinRho SDF (human rho(d) immune globulin), Human rho(D) immune globulin 1500 [iU]/1.3mL injection, solution, listed with the FDA by Kamada Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- WinRho SDF (Human Rho(D) Immune Globulin).
- What is the active ingredient?
- Human rho(D) immune globulin.
- Who is the labeler?
- Kamada Ltd., NDC labeler code 49591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for WinRho SDF?
- 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.