Temodar (temozolomide) NDC 0085-1366

NDC codes

FDA NDC Directory

Product NDC (as listed)0085-1366Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00085-1366Add 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 NDC	11-digit (billing)	Package	Copy
0085-1366-03	00085136603	5 PACKET in 1 CARTON (0085-1366-03) / 1 CAPSULE in 1 PACKET (0085-1366-05)Marketed from Aug 11, 1999
0085-1366-04	00085136604	14 PACKET in 1 CARTON (0085-1366-04) / 1 CAPSULE in 1 PACKET (0085-1366-05)Marketed from Aug 11, 1999

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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Merck Sharp & Dohme LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021029
Marketing start: Aug 11, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 0085-1366_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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400085136603 followed by a unit qualifier and the quantity

Package 00085-1366-03. 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 Feb 20, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021029

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021029
Product	Strength	Form · route	Labeler	Product NDC
Temodartemozolomide	Temozolomide 250 mg/1	CapsuleOral	Merck Sharp & Dohme LLC	0085-1417
Temodartemozolomide	Temozolomide 140 mg/1	CapsuleOral	Merck Sharp & Dohme LLC	0085-1425
Temodartemozolomide	Temozolomide 180 mg/1	CapsuleOral	Merck Sharp & Dohme LLC	0085-1430
Temodartemozolomide	Temozolomide 20 mg/1	CapsuleOral	Merck Sharp & Dohme LLC	0085-1519
Temodartemozolomide	Temozolomide 5 mg/1	CapsuleOral	Merck Sharp & Dohme LLC	0085-3004