What is NDC 61953-0004?

61953-0004 is the product NDC for Flebogamma DIF (immune globulin (human)), Human immunoglobulin g .05 g/mL injection, solution, listed with the FDA by GRIFOLS USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Flebogamma DIF (Immune Globulin (Human)).

GRIFOLS USA, LLC, NDC labeler code 61953. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flebogamma DIF?

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.

Flebogamma DIF NDC 61953-0004 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61953-0004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61953-0004Add 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
61953-0004-3	6195300040361953000403	1 VIAL in 1 CARTON (61953-0004-3) / 100 mL in 1 VIAL (61953-0004-8)Marketed from Dec 21, 2006
61953-0004-4	6195300040461953000404	1 VIAL in 1 CARTON (61953-0004-4) / 200 mL in 1 VIAL (61953-0004-9)Marketed from Dec 21, 2006
61953-0004-5	6195300040561953000405	1 VIAL in 1 CARTON (61953-0004-5) / 400 mL in 1 VIAL (61953-0004-0)Marketed from Dec 21, 2006

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): Flebogamma DIFSuffix: DIF
Generic name (nonproprietary): immune globulin (human)
Active ingredients: Human immunoglobulin g — .05 g/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: GRIFOLS USA, LLCNDC labeler code 61953
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125077
Marketing start: Dec 21, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers: Product ID 61953-0004_6c2e3e83-43fe-48d2-b6a6-7b78870210b7SPL ID 6c2e3e83-43fe-48d2-b6a6-7b78870210b7
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

N461953000403 followed by a unit qualifier and the quantity

Package 61953-0004-03. 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 61953-0004

What is NDC 61953-0004?: 61953-0004 is the product NDC for Flebogamma DIF (immune globulin (human)), Human immunoglobulin g .05 g/mL injection, solution, listed with the FDA by GRIFOLS USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flebogamma DIF (Immune Globulin (Human)).
What is the active ingredient?: Human immunoglobulin g.
Who is the labeler?: GRIFOLS USA, LLC, NDC labeler code 61953. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flebogamma DIF?: 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.

Flebogamma DIF (Immune globulin (human)) NDC 61953-0004