What is NDC 61476-104?

61476-104 is the product NDC for Alyglo (human immunoglobulin g), Human immunoglobulin g 100 mg/mL liquid, listed with the FDA by GC Biopharma Corp.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Alyglo (Human immunoglobulin G).

GC Biopharma Corp., NDC labeler code 61476. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alyglo?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alyglo NDC 61476-104 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61476-104Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61476-0104Add 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
61476-104-05	6147601040561476010405	1 VIAL, GLASS in 1 CARTON (61476-104-05) / 50 mL in 1 VIAL, GLASS (61476-104-01)Marketed from Dec 15, 2023
61476-104-10	6147601041061476010410	1 VIAL, GLASS in 1 CARTON (61476-104-10) / 100 mL in 1 VIAL, GLASS (61476-104-02)Marketed from Dec 15, 2023
61476-104-20	6147601042061476010420	1 VIAL, GLASS in 1 CARTON (61476-104-20) / 200 mL in 1 VIAL, GLASS (61476-104-03)Marketed from Dec 15, 2023

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): Alyglo
Generic name (nonproprietary): human immunoglobulin g
Active ingredients: Human immunoglobulin g — 100 mg/mL
Dosage form: Liquid
Route: Intravenous
Labeler: GC Biopharma Corp.NDC labeler code 61476
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125743
Marketing start: Dec 15, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers: Product ID 61476-104_7e2694c3-ad07-4724-8c50-d7eb4306b375SPL ID 7e2694c3-ad07-4724-8c50-d7eb4306b375
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

N461476010405 followed by a unit qualifier and the quantity

Package 61476-0104-05. 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 61476-104

What is NDC 61476-104?: 61476-104 is the product NDC for Alyglo (human immunoglobulin g), Human immunoglobulin g 100 mg/mL liquid, listed with the FDA by GC Biopharma Corp.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alyglo (Human immunoglobulin G).
What is the active ingredient?: Human immunoglobulin g.
Who is the labeler?: GC Biopharma Corp., NDC labeler code 61476. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alyglo?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Alyglo (Human immunoglobulin g) NDC 61476-104