Prescription drug · ANDA
Temozolomide NDC 70301-2007
Temozolomide 140 mg/1 · Capsule · Oral · OPKO Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70301-2007-1 | 70301200701 | 5 PACKET in 1 CARTON (70301-2007-1) / 1 CAPSULE in 1 PACKETMarketed from Aug 22, 2026 | |
| 70301-2007-2 | 70301200702 | 14 PACKET in 1 CARTON (70301-2007-2) / 1 CAPSULE in 1 PACKETMarketed from Aug 22, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Temozolomide
- Generic name (nonproprietary)
- temozolomide
- Active ingredients
- Temozolomide — 140 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- OPKO Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203898
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 70301-2007_5a0e25c4-dde6-8ac9-e063-6294a90a8e4bSPL ID 5a0e25c4-dde6-8ac9-e063-6294a90a8e4bSPL set ID f6d762ea-fff0-43e8-b67d-bef19e883dd8RxCUI 700883UNII 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
N470301200701followed by a unit qualifier and the quantityPackage 70301-2007-01. 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)
Temozolomide 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 Temozolomide Capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma Temozolomide capsules are indicated for the: • adjuvant treatment of adults with newly diagnosed anaplastic as…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203898
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2011 |
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2005 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2009 |