Prescription drug · ANDA
Temozolomide NDC 47335-930
Temozolomide 180 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-930-21 | 47335093021 | 1 BOTTLE in 1 CARTON (47335-930-21) / 14 CAPSULE in 1 BOTTLEMarketed from Feb 13, 2014 | |
| 47335-930-72 | 47335093072 | 15 BLISTER PACK in 1 CARTON (47335-930-72) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 13, 2014 | |
| 47335-930-74 | 47335093074 | 5 BLISTER PACK in 1 CARTON (47335-930-74) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 13, 2014 | |
| 47335-930-75 | 47335093075 | 20 BLISTER PACK in 1 CARTON (47335-930-75) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 13, 2014 | |
| 47335-930-80 | 47335093080 | 1 BOTTLE in 1 CARTON (47335-930-80) / 5 CAPSULE in 1 BOTTLEMarketed from Feb 13, 2014 | |
| 47335-930-87 | 47335093087 | 1 BOTTLE in 1 CARTON (47335-930-87) / 20 CAPSULE in 1 BOTTLEMarketed from Feb 13, 2014 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201742
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 47335-930_7c774570-443b-40da-8038-7cb550f92048SPL ID 7c774570-443b-40da-8038-7cb550f92048SPL set ID c1e05c21-a411-4493-80de-ede373632475RxCUI 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
N447335093021followed by a unit qualifier and the quantityPackage 47335-0930-21. 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) o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) o 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 a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201742
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 250 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-893 |
| Temozolomide | Temozolomide 5 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-890 |
| Temozolomide | Temozolomide 20 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-891 |
| Temozolomide | Temozolomide 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-892 |
| Temozolomide | Temozolomide 140 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-929 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.