Prescription drug · ANDA
Temozolomide NDC 67877-539
Temozolomide 100 mg/1 · Capsule · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-539-07 | 67877053907 | 5 CAPSULE in 1 BOTTLE (67877-539-07)Marketed from Apr 28, 2017 | |
| 67877-539-14 | 67877053914 | 14 CAPSULE in 1 BOTTLE (67877-539-14)Marketed from Apr 28, 2017 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ascend Laboratories, 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 67877-539_f519f4f0-bb62-43cb-bfc2-15f00ac1aad3SPL ID f519f4f0-bb62-43cb-bfc2-15f00ac1aad3SPL set ID 33d67bce-38ae-45fc-a858-d51167b0ecfdRxCUI 313209, 313210, 313211, 317160, 700883, 700885UNII 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
N467877053907followed by a unit qualifier and the quantityPackage 67877-0539-07. 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, USP 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 ) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMOZOLOMIDE Capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1.2 Refractory Anaplastic Astrocytoma TEMOZOLOMIDE Capsules , USP is indicated for the treatment of adult patient…
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 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 |
| Temozolomide | Temozolomide 20 mg/1 | CapsuleOral | CivicaScript LLC | 82249-406 |
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