Temozolomide

Brand (proprietary) name

None — marketed under its generic name

Generic (nonproprietary) name

Temozolomide

Active ingredient(s)

temozolomide

Strength(s)

100 mg/1; 140 mg/1; 180 mg/1; 20 mg/1; 250 mg/1; 5 mg/1

Dosage form(s)

Capsule

Route(s)

Oral

Manufacturer / labeler

Teva Pharmaceuticals USA, Inc.Sandoz IncAccord Healthcare Inc.ANI Pharmaceuticals, Inc.Sun Pharmaceutical Industries, Inc.AvPAKRising Pharma Holdings, Inc.Amneal Pharmaceuticals LLC

Product class

Authorized generic (derived from FDA marketing category)

Marketing category

ANDA; NDA AUTHORIZED GENERIC

Application number(s)

ANDA078879, ANDA201528, ANDA201742, ANDA203490, ANDA203691, ANDA206309, NDA021029

Earliest marketing start

Aug 12, 2013

Products / packages indexed

44 / 103

FDA pharmacologic class: Alkylating Activity [MoA]; Alkylating Drug [EPC]

Also searchable as: Temozolomide

Prescribing information on DailyMed (NLM)

• J8700JJ-code: Drugs administered other than oral method; chemotherapy drugsActiveDerived calculation

  Temozolomide, oral, 5 mg

  Derived: 79 of 103 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J8700. CMS quarters Q1 2021 – Q4 2026

  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)

• TemodarTemozolomide · J8700, J9328

Which Medicare benefit pays for this drug?

• Coverage documents for temozolomide NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “temozolomide”. Covered diagnosis codes are listed in the articles.
• Coverage documents for J8700 NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “J8700”. Covered diagnosis codes are listed in the articles.

No current Medicare Billing and Coding article lists J8700.

• 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.