Prescription drug · BLA
Nabi-HB (hepatitis b immune globulin (human)) NDC 69800-4203
Human hepatitis b virus immune globulin 1560 [iU]/5mL · Liquid · Intramuscular · ADMA Biologics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69800-4203-1 | 69800420301 | 1 VIAL, SINGLE-USE in 1 CARTON (69800-4203-1) / 5 mL in 1 VIAL, SINGLE-USE (69800-4203-2)Marketed from Oct 23, 2001 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Nabi-HB
- Generic name (nonproprietary)
- hepatitis b immune globulin (human)
- Active ingredients
- Human hepatitis b virus immune globulin — 1560 [iU]/5mL
- Dosage form
- Liquid
- Route
- Intramuscular
- Labeler
- ADMA Biologics, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103945
- 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 69800-4203_3271ce4f-1742-b3b7-e063-6294a90a541dSPL ID 3271ce4f-1742-b3b7-e063-6294a90a541dSPL set ID 47fe1a99-5078-4b89-84fa-9e8387baec5cRxCUI 1658125, 1658127UNII XII270YC6M
- 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
N469800420301followed by a unit qualifier and the quantityPackage 69800-4203-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings: Acute Exposure to Blood Containing HBsAg: Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum. Perinatal Exposure of Infants Born to HBsAg-positive Mothers: Infants born to mothers positive for H…
Excerpt only. Read the full label for complete information.