Plasma derivative · BLA
HepaGam B (Human hepatitis b virus immune globulin) NDC 49591-052
Human hepatitis b virus immune globulin 312 [iU]/mL · Injection, Solution · Intramuscular, Intravenous · Kamada Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49591-052-51 | 4959100525149591005251 | 1 VIAL, GLASS in 1 CARTON (49591-052-51) / 1 mL in 1 VIAL, GLASS (49591-052-11)Marketed from Oct 1, 2025 |
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)
- HepaGam B
- Generic name (nonproprietary)
- human hepatitis b virus immune globulin
- Active ingredients
- Human hepatitis b virus immune globulin — 312 [iU]/mL
- 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 125035
- 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 49591-052_5dbdf1e3-5468-2369-e063-6394a90a3215SPL ID 5dbdf1e3-5468-2369-e063-6394a90a3215
- 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
N449591005251followed by a unit qualifier and the quantityPackage 49591-0052-51. 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 49591-052
- What is NDC 49591-052?
- 49591-052 is the product NDC for HepaGam B (human hepatitis b virus immune globulin), Human hepatitis b virus immune globulin 312 [iU]/mL 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?
- HepaGam B (Human hepatitis b virus immune globulin).
- What is the active ingredient?
- Human hepatitis b virus 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 HepaGam B?
- 1 other product NDC are listed under this name. See all HepaGam B NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other HepaGam B products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| HepaGam Bhuman hepatitis b virus immune globulin | Human hepatitis b virus immune globulin 312 [iU]/mL | Injection, SolutionIntramuscular, Intravenous | Kamada Ltd. | 49591-051 | 49591-0051-51 |
Other NDCs under BLA 125035
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| HepaGam Bhuman hepatitis b virus immune globulin | Human hepatitis b virus immune globulin 312 [iU]/mL | Injection, SolutionIntramuscular, Intravenous | Kamada Ltd. | 49591-051 |