Prescription drug · BLA
Thymoglobulin (Anti-thymocyte globulin (rabbit)) NDC 58468-0080
Lapine t-lymphocyte immune globulin 5 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0080-1 | 5846800800158468008001 | 1 VIAL, GLASS in 1 CARTON (58468-0080-1) / 5 mL in 1 VIAL, GLASSMarketed from Dec 30, 1998 |
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)
- Thymoglobulin
- Generic name (nonproprietary)
- anti-thymocyte globulin (rabbit)
- Active ingredients
- Lapine t-lymphocyte immune globulin — 5 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genzyme CorporationNDC labeler code 58468
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103869
- Marketing start
- Listing expires
- Other FDA classes
- Antibody-Surface Protein Interactions (Mechanism)Immunoglobulins (Chemical structure)Increased T Lymphocyte Destruction (Physiologic effect)Lymphocyte Function Alteration (Physiologic effect)
- Identifiers
- Product ID 58468-0080_1e694a66-3d88-498c-ae79-47bc6f1c7b7dSPL ID 1e694a66-3d88-498c-ae79-47bc6f1c7b7dSPL set ID bbd8ab99-552e-4b81-aca4-6b0c7af8b9aeRxCUI 107047, 107050UNII D7RD81HE4W
- Pharmacologic class
- 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
N458468008001followed by a unit qualifier and the quantityPackage 58468-0080-01. 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 .
Indications (excerpt from the label)
THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression. THYMOGLOBULIN is an immunoglobulin G indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58468-0080
- What is NDC 58468-0080?
- 58468-0080 is the product NDC for Thymoglobulin (anti-thymocyte globulin (rabbit)), Lapine t-lymphocyte immune globulin 5 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Thymoglobulin (Anti-thymocyte Globulin (Rabbit)).
- What is the active ingredient?
- Lapine t-lymphocyte immune globulin.
- Who is the labeler?
- Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Thymoglobulin?
- 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.