Gammaplex (human immunoglobulin g) NDC 64208-8235

NDC codes

FDA NDC Directory

Product NDC (as listed)64208-8235Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64208-8235Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
64208-8235-5	64208823505	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	64208823506	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	64208823507	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 Ltd
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125329
Marketing start: Apr 7, 2017
Listing expires: Dec 31, 2026
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.

How CPT relates to drug billing

NDC on a medical claim

N464208823505 followed by a unit qualifier and the quantity

Package 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.

Other NDCs under BLA 125329

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125329
Product	Strength	Form · route	Labeler	Product NDC
Gammaplexhuman immunoglobulin g	Human immunoglobulin g 5 g/100mL	SolutionIntravenous	Bio Products Laboratory Limited	64208-8234