Prescription drug · BLA
Trogarzo (Ibalizumab) NDC 62064-122
Ibalizumab 150 mg/mL · Injection, Solution · Intravenous · Theratechnologies Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62064-122-02 | 62064012202 | 2 VIAL, SINGLE-USE in 1 CARTON (62064-122-02) / 1.33 mL in 1 VIAL, SINGLE-USE (62064-122-01)Marketed from Apr 20, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Trogarzo
- Generic name (nonproprietary)
- ibalizumab
- Active ingredients
- Ibalizumab — 150 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Theratechnologies Inc.NDC labeler code 62064
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761065
- Marketing start
- Listing expires
- Other FDA classes
- Humanized (Chemical structure)CD4-directed Antibody Interactions (Mechanism)HIV 1 Post-attachment Fusion Inhibitors (Mechanism)
- Identifiers
- Product ID 62064-122_c04624be-0e28-4902-954c-730ccdbfd162SPL ID c04624be-0e28-4902-954c-730ccdbfd162SPL set ID c548ad82-9d1f-4d16-95b6-4e6106badf43RxCUI 2043317, 2043322UNII LT369U66CE
- Pharmacologic class
- CD4-directed Blocking Antibody; Human Immunodeficiency Virus 1 Post-attachment Fusion Inhibitor
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
N462064012202followed by a unit qualifier and the quantityPackage 62064-0122-02. 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)
TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Excerpt only. Read the full label for complete information.
About NDC 62064-122
- What is NDC 62064-122?
- 62064-122 is the product NDC for Trogarzo (ibalizumab), Ibalizumab 150 mg/mL injection, solution, listed with the FDA by Theratechnologies Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trogarzo (Ibalizumab).
- What is the active ingredient?
- Ibalizumab.
- Who is the labeler?
- Theratechnologies Inc., NDC labeler code 62064. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trogarzo?
- 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.