HepaGam B (human hepatitis b virus immune globulin) NDC 49591-052

NDC codes

FDA NDC Directory

Product NDC (as listed)49591-052Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49591-0052Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
49591-052-51	49591005251	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.
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125035
Marketing start: Oct 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)Virus Neutralization (Mechanism)Virus-specific Hyperimmune Globulins (EXT)
Identifiers: Product ID 49591-052_4c139c86-d0dc-1a10-e063-6294a90a8e1dSPL ID 4c139c86-d0dc-1a10-e063-6294a90a8e1d
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.

How CPT relates to drug billing

NDC on a medical claim

N449591005251 followed by a unit qualifier and the quantity

Package 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.

Other NDCs under BLA 125035

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125035
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