Plasma derivative · BLA
Panzyga (immune globulin intravenous (human)) NDC 0069-1558
Human immunoglobulin g 100 mg/mL · Solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-1558-02 | 00069155802 | 1 BOTTLE, GLASS in 1 CARTON (0069-1558-02) / 300 mL in 1 BOTTLE, GLASS (0069-1558-01)Marketed from Aug 9, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Panzyga
- Generic name (nonproprietary)
- immune globulin intravenous (human)
- Active ingredients
- Human immunoglobulin g — 100 mg/mL
- Dosage form
- Solution
- Route
- Intravenous
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125587
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 0069-1558_fb008bad-3696-e7b9-d3f8-3718e16e19d8SPL ID fb008bad-3696-e7b9-d3f8-3718e16e19d8
- 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
N400069155802followed by a unit qualifier and the quantityPackage 00069-1558-02. 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 125587
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 |
|---|---|---|---|---|
| Panzygaimmune globulin intravenous (human) | Human immunoglobulin g 100 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-1224 |
| Panzygaimmune globulin intravenous (human) | Human immunoglobulin g 100 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-1312 |
| Panzygaimmune globulin intravenous (human) | Human immunoglobulin g 100 mg/mL | SolutionIntravenous | Octapharma USA Inc | 68982-822 |
| Panzygaimmune globulin intravenous (human) | Human immunoglobulin g 100 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-1109 |
| Panzygaimmune globulin intravenous (human) | Human immunoglobulin g 100 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-1415 |
| Panzygaimmune globulin intravenous (human) | Human immunoglobulin g 100 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-1011 |