Prescription drug · NDA
Temodar (Temozolomide) NDC 0085-1381
Temozolomide 2.5 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0085-1381-01 | 0008513810100085138101 | 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USEMarketed from Feb 27, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Temodar
- Generic name (nonproprietary)
- temozolomide
- Active ingredients
- Temozolomide — 2.5 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0085
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022277
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 0085-1381_40ceddc0-83a2-4b3b-8953-fd0078a41133SPL ID 40ceddc0-83a2-4b3b-8953-fd0078a41133SPL set ID 046a9011-3911-4d3f-a15f-fbb56d5aad56RxCUI 261288, 261289, 261290, 261291, 313209, 313210, 313211, 317160, 700883, 700885, 705617, 705619, 835945, 835948UNII YF1K15M17Y
- Pharmacologic class
- Alkylating Drug
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
N400085138101followed by a unit qualifier and the quantityPackage 00085-1381-01. 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)
TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma. ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with …
Excerpt only. Read the full label for complete information.
About NDC 0085-1381
- What is NDC 0085-1381?
- 0085-1381 is the product NDC for Temodar (temozolomide), Temozolomide 2.5 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Temodar (Temozolomide).
- What is the active ingredient?
- Temozolomide.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Temodar?
- 6 other product NDCs are listed under this name. See all Temodar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Temodar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Temodartemozolomide | Temozolomide 100 mg/1 | CapsuleOral | Merck Sharp & Dohme LLC | 0085-1366 | 00085-1366-0300085-1366-04 |
| Temodartemozolomide | Temozolomide 250 mg/1 | CapsuleOral | Merck Sharp & Dohme LLC | 0085-1417 | 00085-1417-02 |
| Temodartemozolomide | Temozolomide 140 mg/1 | CapsuleOral | Merck Sharp & Dohme LLC | 0085-1425 | 00085-1425-0300085-1425-04 |
| Temodartemozolomide | Temozolomide 180 mg/1 | CapsuleOral | Merck Sharp & Dohme LLC | 0085-1430 | 00085-1430-0300085-1430-04 |
| Temodartemozolomide | Temozolomide 20 mg/1 | CapsuleOral | Merck Sharp & Dohme LLC | 0085-1519 | 00085-1519-0300085-1519-04 |
| Temodartemozolomide | Temozolomide 5 mg/1 | CapsuleOral | Merck Sharp & Dohme LLC | 0085-3004 | 00085-3004-0300085-3004-04 |