Plasma derivative · BLA
Hyperrho Mini-Dose (rho(d) immune globulin (human)) NDC 13533-661
Human rho(D) immune globulin 250 [iU]/mL · Solution · Intramuscular · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13533-661-06 | 13533066106 | 10 SYRINGE in 1 CARTON (13533-661-06) / 1 mL in 1 SYRINGE (13533-661-60)Marketed from Aug 14, 1996 |
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)
- Hyperrho Mini-DoseSuffix: MINI-DOSE
- Generic name (nonproprietary)
- rho(d) immune globulin (human)
- Active ingredients
- Human rho(D) immune globulin — 250 [iU]/mL
- Dosage form
- Solution
- Route
- Intramuscular
- Labeler
- GRIFOLS USA, LLC
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 101141
- Marketing start
- Listing expires
- Other FDA classes
- Endogenous Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 13533-661_cc33dfe9-295d-4ade-a303-6986d2fe190aSPL ID cc33dfe9-295d-4ade-a303-6986d2fe190a
- 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
N413533066106followed by a unit qualifier and the quantityPackage 13533-0661-06. 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.