Gammaked (immune globulin (human)) NDC 76125-900

NDC codes

FDA NDC Directory

Product NDC (as listed)76125-900Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76125-0900Add 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
76125-900-01	76125090001	1 VIAL, GLASS in 1 CARTON (76125-900-01) / 10 mL in 1 VIAL, GLASS (76125-900-02)Marketed from Oct 13, 2010
76125-900-10	76125090010	1 VIAL, GLASS in 1 CARTON (76125-900-10) / 100 mL in 1 VIAL, GLASS (76125-900-11)Marketed from Oct 13, 2010
76125-900-20	76125090020	1 VIAL, GLASS in 1 CARTON (76125-900-20) / 200 mL in 1 VIAL, GLASS (76125-900-21)Marketed from Oct 13, 2010
76125-900-25	76125090025	1 VIAL, GLASS in 1 CARTON (76125-900-25) / 25 mL in 1 VIAL, GLASS (76125-900-26)Marketed from Oct 13, 2010
76125-900-50	76125090050	1 VIAL, GLASS in 1 CARTON (76125-900-50) / 50 mL in 1 VIAL, GLASS (76125-900-51)Marketed from Oct 13, 2010

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Gammaked
Generic name (nonproprietary): immune globulin (human)
Active ingredients: Human immunoglobulin g — 10 g/100mL
Dosage form: Injection
Route: Intravenous, Subcutaneous
Labeler: KEDRION BIOPHARMA, INC.
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125046
Marketing start: Oct 13, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers: Product ID 76125-900_a7b621b8-b33b-4ece-b7ba-7d63f8ec7018SPL ID a7b621b8-b33b-4ece-b7ba-7d63f8ec7018
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

N476125090001 followed by a unit qualifier and the quantity

Package 76125-0900-01. 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.

Other NDCs under BLA 125046

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

FDA NDC Directory listings under BLA 125046
Product	Strength	Form · route	Labeler	Product NDC
Gamunex-Cimmune globulin (human)	Human immunoglobulin g 10 g/100mL	InjectionIntravenous	GRIFOLS USA, LLC	13533-805
Gamunex-Cimmune globulin (human)	Human immunoglobulin g 10 g/100mL	InjectionIntravenous, Subcutaneous	GRIFOLS USA, LLC	13533-800