Prescription drug · ANDA
Temozolomide NDC 65162-801
Temozolomide 5 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-801-14 | 65162080114 | 1 BOTTLE in 1 CARTON (65162-801-14) / 14 CAPSULE in 1 BOTTLEMarketed from Apr 3, 2015 | |
| 65162-801-51 | 65162080151 | 1 BOTTLE in 1 CARTON (65162-801-51) / 5 CAPSULE in 1 BOTTLEMarketed from Apr 3, 2015 |
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 — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203691
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 65162-801_7cf62d84-45c0-405c-975b-3dbcbcf5ee27SPL ID 7cf62d84-45c0-405c-975b-3dbcbcf5ee27SPL set ID 6c8529ec-8936-4fec-a1a5-2b285c7e4859RxCUI 313209, 313210, 313211, 317160, 700883, 700885UNII YF1K15M17YUPC 0365162803518, 0365162802511, 0365162805512, 0365162804515, 0365162806519, 0365162801514
- 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
N465162080114followed by a unit qualifier and the quantityPackage 65162-0801-14. 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 capsules are 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 anap…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203691
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 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-802 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-805 |
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-803 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-804 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-806 |