NDC codes

FDA NDC Directory
Product NDC (as listed)58468-0080Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58468-0080Add 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
58468-0080-158468008001584680080011 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.

How CPT relates to drug billing

NDC on a medical claim

N458468008001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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