Prescription drug · BLA
Asceniv (human immunoglobulin g) NDC 69800-0250
Human immunoglobulin g 5 g/50mL · Liquid · Intravenous · ADMA Biologics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69800-0250-1 | 69800025001 | 1 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
- Labeler
- ADMA Biologics, Inc.
- 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.
- NDC on a medical claim
N469800025001followed by a unit qualifier and the quantityPackage 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.