Fusilev

Brand (proprietary) name

FUSILEV

Generic (nonproprietary) name

No authoritative public data was located for this field.

Active ingredient(s)

No authoritative public data was located for this field.

Strength(s)

No authoritative public data was located for this field.

Dosage form(s)

No authoritative public data was located for this field.

Route(s)

No authoritative public data was located for this field.

Manufacturer / labeler

Acrotech Biopharma Inc

Product class

Brand (derived from FDA marketing category)

Marketing category

NDA

Application number(s)

NDA020140

Earliest marketing start

Aug 15, 2008

Products / packages indexed

1 / 1

Also searchable as: FUSILEV · Levoleucovorin Calcium

Prescribing information on DailyMed (NLM)

• J0641JJ-code: Drugs administered other than oral method; chemotherapy drugsActiveNOC / NOSDerived calculation

  Injection, levoleucovorin, not otherwise specified, 0.5 mg

  Derived: 1 of 1 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J0641. CMS quarters Q1 2021 – Q2 2022Not in the latest CMS crosswalk.

  J-codes are permanent national codes for drugs and biologicals — most often clinician-administered (buy-and-bill) products paid under Medicare Part B — plus certain immunosuppressive, inhalation (via DME), and oral anticancer/antiemetic drugs. Units are reported in multiples of the dosage in the code descriptor.

Other drugs crosswalked to the same code(s)

• Levoleucovorin · J0641
• LevoleucovorinLevoleucovorin · J0641
• Levoleucovorinlevoleucovorin calcium · J0641
• Levoleucovorin CalciumLevoleucovorin · J0641
• Levoleucovorin Calciumlevoleucovorin injection · J0641

Which Medicare benefit pays for this drug?

• Coverage documents for J0641 NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “J0641”. Covered diagnosis codes are listed in the articles.
• Self-administered drug (SAD) exclusion lists Drugs each MAC excludes from “incident to” Part B coverage because they are usually self-administered.

No current Medicare Billing and Coding article lists J0641.

• FDA NDC Directory data is submitted by labelers; FDA notes that inclusion does not mean the information was verified or that a product is approved, covered, or reimbursable.
• HCPCS links are derived from CMS NDC–HCPCS crosswalks, which support ASP-based Part B payment and are not a complete list of billable NDCs.
• Product class (brand, generic, biosimilar) is derived from the FDA marketing category and Purple Book license type, not from a commercial compendium.
• Payment limits are Medicare Part B national limits; they do not reflect payer contracts, OPPS rates, 340B pricing, or acquisition cost.
• Home infusion per diem S-codes are matched by therapy category from the FDA pharmacologic class and route, not from a CMS crosswalk. Payers choose which per diem codes they accept, and the right code can depend on the dosing schedule, infusion method, or daily volume.