Prescription drug · ANDA
Temozolomide NDC 82249-412
Temozolomide 180 mg/1 · Capsule · Oral · CivicaScript LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82249-412-05 | 82249041205 | 5 CAPSULE in 1 BOTTLE (82249-412-05)Marketed from Aug 10, 2026 | |
| 82249-412-14 | 82249041214 | 14 CAPSULE in 1 BOTTLE (82249-412-14)Marketed from Aug 10, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Temozolomide
- Generic name (nonproprietary)
- temozolomide
- Active ingredients
- Temozolomide — 180 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- CivicaScript LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207658
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 82249-412_33d123b1-aaa5-4f83-bc6a-f9ebc82b228bSPL ID 33d123b1-aaa5-4f83-bc6a-f9ebc82b228bSPL set ID 56245d21-4a42-471e-bbdc-80b129336e2fRxCUI 313209, 313210, 313211, 317160, 700883, 700885UNII YF1K15M17YUPC 0382249404147, 0382249406141, 0382249410148, 0382249412142, 0382249408145
- 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
N482249041205followed by a unit qualifier and the quantityPackage 82249-0412-05. 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)
1. INDICATIONS AND USAGE TEMOZOLOMIDE Capsules are an alkylating drug indicated for the treatment of adult patients 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 is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMOZOLOMIDE Capsules is indicated for the: adjuvant treatment of ad…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207658
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 | Ascend Laboratories, LLC | 67877-539 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-537 |
| Temozolomide | Temozolomide 20 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-538 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-540 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-541 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-542 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | Devatis, Inc. | 73043-011 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | Devatis, Inc. | 73043-014 |
| Temozolomide | Temozolomide 20 mg/1 | CapsuleOral | Devatis, Inc. | 73043-012 |
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | Devatis, Inc. | 73043-013 |
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2661 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | Devatis, Inc. | 73043-015 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2659 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | Devatis, Inc. | 73043-016 |
| Temozolomide | Temozolomide 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2660 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2664 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2662 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2663 |
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | CivicaScript LLC | 82249-408 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | CivicaScript LLC | 82249-404 |
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