Plasma derivative · BLA
Gammaplex (Human immunoglobulin g) NDC 64208-8235
Human immunoglobulin g 5 g/50mL · Solution · Intravenous · Bio Products Laboratory Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64208-8235-5 | 6420882350564208823505 | 1 BOTTLE, GLASS in 1 CARTON (64208-8235-5) / 50 mL in 1 BOTTLE, GLASS (64208-8235-1)Marketed from Apr 7, 2017 | |
| 64208-8235-6 | 6420882350664208823506 | 1 BOTTLE, GLASS in 1 CARTON (64208-8235-6) / 100 mL in 1 BOTTLE, GLASS (64208-8235-2)Marketed from Apr 7, 2017 | |
| 64208-8235-7 | 6420882350764208823507 | 1 BOTTLE, GLASS in 1 CARTON (64208-8235-7) / 200 mL in 1 BOTTLE, GLASS (64208-8235-3)Marketed from Apr 7, 2017 |
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)
- Gammaplex
- Generic name (nonproprietary)
- human immunoglobulin g
- Active ingredients
- Human immunoglobulin g — 5 g/50mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- Bio Products Laboratory LtdNDC labeler code 64208
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125329
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 64208-8235_a1aa7eb5-47eb-4da5-b8ad-d32b52594a2eSPL ID a1aa7eb5-47eb-4da5-b8ad-d32b52594a2e
- 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
N464208823505followed by a unit qualifier and the quantityPackage 64208-8235-05. 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 64208-8235
- What is NDC 64208-8235?
- 64208-8235 is the product NDC for Gammaplex (human immunoglobulin g), Human immunoglobulin g 5 g/50mL solution, listed with the FDA by Bio Products Laboratory Ltd. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gammaplex (Human immunoglobulin g).
- What is the active ingredient?
- Human immunoglobulin g.
- Who is the labeler?
- Bio Products Laboratory Ltd, NDC labeler code 64208. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gammaplex?
- 1 other product NDC are listed under this name. See all Gammaplex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gammaplex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gammaplexhuman immunoglobulin g | Human immunoglobulin g 5 g/100mL | SolutionIntravenous | Bio Products Laboratory Limited | 64208-8234 | 64208-8234-0664208-8234-0764208-8234-08 |
Other NDCs under BLA 125329
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 |
|---|---|---|---|---|
| Gammaplexhuman immunoglobulin g | Human immunoglobulin g 5 g/100mL | SolutionIntravenous | Bio Products Laboratory Limited | 64208-8234 |