Prescription drug · ANDA
Temozolomide NDC 70301-2001
Temozolomide 5 mg/1 · Capsule · Oral · OPKO Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70301-2001-1 | 7030120010170301200101 | 5 PACKET in 1 CARTON (70301-2001-1) / 1 CAPSULE in 1 PACKETMarketed from Oct 31, 2026 | |
| 70301-2001-2 | 7030120010270301200102 | 14 PACKET in 1 CARTON (70301-2001-2) / 1 CAPSULE in 1 PACKETMarketed from Oct 31, 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 — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- OPKO Pharmaceuticals, LLCNDC labeler code 70301
- 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 70301-2001_579d95fb-4bd5-688a-e063-6294a90aa90eSPL ID 579d95fb-4bd5-688a-e063-6294a90aa90eSPL set ID bf47f075-67cd-4aa2-b56d-1b46bf3c3af5UNII YF1K15M17YUPC 0370301200110
- 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
N470301200101followed by a unit qualifier and the quantityPackage 70301-2001-01. 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.
About NDC 70301-2001
- What is NDC 70301-2001?
- 70301-2001 is the product NDC for Temozolomide, Temozolomide 5 mg/1 capsule, listed with the FDA by OPKO Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Temozolomide.
- What is the active ingredient?
- Temozolomide.
- Who is the labeler?
- OPKO Pharmaceuticals, LLC, NDC labeler code 70301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Temozolomide?
- 63 other product NDCs are listed under this name. See all Temozolomide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Temozolomide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2005 | 70301-2005-0170301-2005-02 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2007 | 70301-2007-0170301-2007-02 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2009 | 70301-2009-0170301-2009-02 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2011 | 70301-2011-01 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | CivicaScript LLC | 82249-404 | 82249-0404-0582249-0404-14 |
| Temozolomide | Temozolomide 20 mg/1 | CapsuleOral | CivicaScript LLC | 82249-406 | 82249-0406-0582249-0406-14 |
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | CivicaScript LLC | 82249-408 | 82249-0408-0582249-0408-14 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | CivicaScript LLC | 82249-410 | 82249-0410-0582249-0410-14 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | CivicaScript LLC | 82249-412 | 82249-0412-0582249-0412-14 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | CivicaScript LLC | 82249-414 | 82249-0414-05 |
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 100 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2005 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2007 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2009 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2011 |