Gammagard S/D NDC 0944-2658

NDC codes

FDA NDC Directory

Product NDC (as listed)0944-2658Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00944-2658Add 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	Copy
0944-2658-04	00944265804	1 KIT in 1 CARTON (0944-2658-04) * 192 mL in 1 BOTTLE (0338-0001-37) * 192 mL in 1 BOTTLE (64764-511-92) * 200 mL in 1 BOTTLE (0944-2659-08)Marketed from May 10, 1994

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Gammagard S/DSuffix: S/D
Generic name (nonproprietary): immune globulin intravenous (human)
Dosage form: Kit
Labeler: Takeda Pharmaceuticals America, Inc.
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 103133
Marketing start: May 10, 1994
Listing expires: Dec 31, 2026
Identifiers: Product ID 0944-2658_123bfa78-6fbe-41c7-8e01-c885e58c1437SPL ID 123bfa78-6fbe-41c7-8e01-c885e58c1437

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.

NDC on a medical claim

N400944265804 followed by a unit qualifier and the quantity

Package 00944-2658-04. 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 103133

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

FDA NDC Directory listings under BLA 103133
Product	Strength	Form · route	Labeler	Product NDC
Gammagard S/Dimmune globulin intravenous (human)	—	Kit	Takeda Pharmaceuticals America, Inc.	0944-2656

Gammagard S/D (immune globulin intravenous (human)) NDC 0944-2658