NDC codes

FDA NDC Directory
Product NDC (as listed)62064-122Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62064-0122Add 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
62064-122-02620640122022 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.

How CPT relates to drug billing

NDC on a medical claim

N462064012202 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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