Plasma derivative · BLA
Cuvitru (immune globulin subcutaneous (human)) NDC 0944-2850
Human immunoglobulin g 200 mg/mL · Injection, Solution · Subcutaneous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0944-2850-01 | 00944285001 | 1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01) / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02)Marketed from Oct 18, 2016 | |
| 0944-2850-03 | 00944285003 | 1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-03) / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04)Marketed from Oct 18, 2016 | |
| 0944-2850-05 | 00944285005 | 1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-05) / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06)Marketed from Oct 18, 2016 | |
| 0944-2850-07 | 00944285007 | 1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-07) / 40 mL in 1 VIAL, SINGLE-USE (0944-2850-08)Marketed from Oct 18, 2016 | |
| 0944-2850-09 | 00944285009 | 1 BOTTLE, GLASS in 1 CARTON (0944-2850-09) / 50 mL in 1 BOTTLE, GLASS (0944-2850-10)Marketed from Oct 18, 2016 |
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)
- Cuvitru
- Generic name (nonproprietary)
- immune globulin subcutaneous (human)
- Active ingredients
- Human immunoglobulin g — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125596
- Marketing start
- Listing expires
- Other FDA classes
- Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
- Identifiers
- Product ID 0944-2850_195585b0-5cd1-4638-9765-224db70d6e44SPL ID 195585b0-5cd1-4638-9765-224db70d6e44
- 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
N400944285001followed by a unit qualifier and the quantityPackage 00944-2850-01. 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.