Prescription drug · ANDA
Temozolomide NDC 16571-818
Temozolomide 100 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-818-02 | 16571081802 | 20 CAPSULE in 1 BOTTLE (16571-818-02)Marketed from Oct 4, 2022 | |
| 16571-818-41 | 16571081841 | 14 CAPSULE in 1 BOTTLE (16571-818-41)Marketed from Oct 4, 2022 | |
| 16571-818-51 | 16571081851 | 5 CAPSULE in 1 BOTTLE (16571-818-51)Marketed from Oct 4, 2022 |
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
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206309
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 16571-818_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5SPL ID b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5SPL set ID 70996a9d-4a4f-4ed1-ab07-130486aa14abRxCUI 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
N416571081802followed by a unit qualifier and the quantityPackage 16571-0818-02. 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 ast…
Excerpt only. Read the full label for complete information.
About NDC 16571-818
- What is NDC 16571-818?
- 16571-818 is the product NDC for Temozolomide, Temozolomide 100 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 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?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 20 mg/1 | CapsuleOral | CivicaScript LLC | 82249-406 | 82249-0406-0582249-0406-14 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | CivicaScript LLC | 82249-404 | 82249-0404-0582249-0404-14 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | CivicaScript LLC | 82249-412 | 82249-0412-0582249-0412-14 |
| 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 250 mg/1 | CapsuleOral | CivicaScript LLC | 82249-414 | 82249-0414-05 |
Other NDCs under ANDA 206309
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 140 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-819 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-816 |
| Temozolomide | Temozolomide 20 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-817 |
| Temozolomide | Temozolomide 180 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-820 |
| Temozolomide | Temozolomide 250 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-821 |