NDC codes

FDA NDC Directory
Product NDC (as listed)69800-0250Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69800-0250Add 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 NDC11-digit (billing)PackageCopy
69800-0250-1698000250011 VIAL, SINGLE-USE in 1 CARTON (69800-0250-1) / 50 mL in 1 VIAL, SINGLE-USE (69800-0250-2)Marketed from Apr 1, 2019

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)
Asceniv
Generic name (nonproprietary)
human immunoglobulin g
Active ingredients
Human immunoglobulin g — 5 g/50mL
Dosage form
Liquid
Route
Intravenous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125590
Marketing start
Listing expires
Other FDA classes
Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers
Product ID 69800-0250_4ecc6123-99fa-fa43-e063-6294a90a548fSPL ID 4ecc6123-99fa-fa43-e063-6294a90a548fSPL set ID d74f4360-3b51-496c-96fb-84c3976958d2RxCUI 2123037, 2123042UNII 66Y330CJHSUPC 0369800025027
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

N469800025001 followed by a unit qualifier and the quantity

Package 69800-0250-01. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

ASCENIV is indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID). ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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