Prescription drug · BLA
Bivigam (immune globulin intravenous (human) 10%) NDC 69800-6502
Human immunoglobulin g 5 g/50mL · Injection, Solution · Intravenous · ADMA Biologics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69800-6502-1 | 69800650201 | 1 VIAL, SINGLE-USE in 1 CARTON (69800-6502-1) / 50 mL in 1 VIAL, SINGLE-USE (69800-6502-2)Marketed from Jan 21, 2013 |
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)
- Bivigam
- Generic name (nonproprietary)
- immune globulin intravenous (human) 10%
- Active ingredients
- Human immunoglobulin g — 5 g/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ADMA Biologics, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125389
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 69800-6502_3469d327-8d5d-fff5-e063-6394a90a2cf2SPL ID 3469d327-8d5d-fff5-e063-6394a90a2cf2SPL set ID a2244aa0-a6d0-11df-b385-0002a5d5c51bRxCUI 1809414, 1809416, 1809421, 1809422UNII 66Y330CJHSUPC 0369800650328, 0369800650229
- 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
N469800650201followed by a unit qualifier and the quantityPackage 69800-6502-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). [1] 1.1 Primary Humoral Immunodeficiency BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125389
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 |
|---|---|---|---|---|
| Bivigamimmune globulin intravenous (human) 10% | Human immunoglobulin g 10 g/100mL | Injection, SolutionIntravenous | ADMA Biologics, Inc. | 69800-6503 |