Albutein (Albumin (human)) NDC 68516-5218

Product information

Brand name (proprietary)

Albutein

Generic name (nonproprietary)

albumin (human)

Active ingredients

Albumin human — 12.5 g/250mL

Dosage form

Injection, Solution

Route

Intravenous

Labeler

GRIFOLS USA, LLCNDC labeler code 68516

Product type

Plasma derivative

Marketing category

BLA — Biologics License ApplicationApplication BLA 102478

Marketing start

Nov 15, 2023

Listing expires

Dec 31, 2027

Other FDA classes

Increased Intravascular Volume (Physiologic effect)Increased Oncotic Pressure (Physiologic effect)Osmotic Activity (Mechanism)Serum Albumin (Chemical/Ingredient)

Identifiers

Product ID 68516-5218_9d44a61a-a597-490f-bd3f-f537da1efc01SPL ID 9d44a61a-a597-490f-bd3f-f537da1efc01

Pharmacologic class

Human Serum Albumin

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

N468516521801 followed by a unit qualifier and the quantity Copy

Package 68516-5218-01. 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.

About NDC 68516-5218

What is NDC 68516-5218?

68516-5218 is the product NDC for Albutein (albumin (human)), Albumin human 12.5 g/250mL injection, solution, listed with the FDA by GRIFOLS USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Albutein (Albumin (Human)).

What is the active ingredient?

Albumin human.

Who is the labeler?

GRIFOLS USA, LLC, NDC labeler code 68516. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Albutein?

6 other product NDCs are listed under this name. See all Albutein NDCs.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory. See Billing references above.

Related NDCs: other Albutein products

Other finished products listed under the same name: strengths, forms and labelers.

Other NDCs under BLA 102478

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