Octagam Immune Globulin (Human) (immune globulin) NDC 0069-8451

Product information

Brand name (proprietary)

Octagam Immune Globulin (Human)

Generic name (nonproprietary)

immune globulin

Active ingredients

Human immunoglobulin g — 50 mg/mL

Dosage form

Solution

Route

Intravenous

Labeler

Pfizer Laboratories Div Pfizer Inc

Product type

Plasma derivative

Marketing category

BLA — Biologics License ApplicationApplication BLA 125062

Marketing start

Nov 13, 2023

Listing expires

Dec 31, 2026

Other FDA classes

Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)

Identifiers

Product ID 0069-8451_a08c35a4-9c25-5ceb-f3c4-0901519057b9SPL ID a08c35a4-9c25-5ceb-f3c4-0901519057b9

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

N400069845102 followed by a unit qualifier and the quantity Copy

Package 00069-8451-02. 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 125062

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