Plasma derivative · BLA
Hyperhep B (hepatitis b immune globulin (human)) NDC 13533-636
Human hepatitis b virus immune globulin 220 [iU]/mL · Injection · Intramuscular · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13533-636-01 | 13533063601 | 1 VIAL, GLASS in 1 CARTON (13533-636-01) / 1 mL in 1 VIAL, GLASS (13533-636-10)Marketed from Oct 9, 1996 | |
| 13533-636-02 | 13533063602 | 1 SYRINGE, GLASS in 1 CARTON (13533-636-02) / 1 mL in 1 SYRINGE, GLASS (13533-636-20)Marketed from Oct 9, 1996 | |
| 13533-636-03 | 13533063603 | 1 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30)Marketed from Oct 9, 1996 | |
| 13533-636-05 | 13533063605 | 1 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50)Marketed from Oct 9, 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)
- Hyperhep B
- Generic name (nonproprietary)
- hepatitis b immune globulin (human)
- Active ingredients
- Human hepatitis b virus immune globulin — 220 [iU]/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- GRIFOLS USA, LLC
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 101146
- 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 13533-636_07a45b19-8ed3-48e2-9c0f-9620437fd452SPL ID 07a45b19-8ed3-48e2-9c0f-9620437fd452
- Pharmacologic class
- Human Immunoglobulin
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
N413533063601followed by a unit qualifier and the quantityPackage 13533-0636-01. 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.