Prescription drug · BLA
Bivigam (Immune globulin intravenous (human) 10%) NDC 69800-6503
Human immunoglobulin g 10 g/100mL · Injection, Solution · Intravenous · ADMA Biologics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69800-6503-1 | 6980065030169800650301 | 1 VIAL, SINGLE-USE in 1 CARTON (69800-6503-1) / 100 mL in 1 VIAL, SINGLE-USE (69800-6503-2)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 — 10 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ADMA Biologics, Inc.NDC labeler code 69800
- 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 69800-6503_5c911b88-a905-773c-e063-6294a90ac2bdSPL ID 5c911b88-a905-773c-e063-6294a90ac2bd
- 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
N469800650301followed by a unit qualifier and the quantityPackage 69800-6503-01. 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.
About NDC 69800-6503
- What is NDC 69800-6503?
- 69800-6503 is the product NDC for Bivigam (immune globulin intravenous (human) 10%), Human immunoglobulin g 10 g/100mL injection, solution, listed with the FDA by ADMA Biologics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bivigam (Immune Globulin Intravenous (Human) 10%).
- What is the active ingredient?
- Human immunoglobulin g.
- Who is the labeler?
- ADMA Biologics, Inc., NDC labeler code 69800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bivigam?
- 1 other product NDC are listed under this name. See all Bivigam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bivigam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bivigamimmune globulin intravenous (human) 10% | Human immunoglobulin g 5 g/50mL | Injection, SolutionIntravenous | ADMA Biologics, Inc. | 69800-6502 | 69800-6502-01 |
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 5 g/50mL | Injection, SolutionIntravenous | ADMA Biologics, Inc. | 69800-6502 |