Prescription drug · NDA
Hycamtin (Topotecan) NDC 66758-102
Topotecan hydrochloride 1 mg/1 · Capsule · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66758-102-11 | 66758010211 | 10 CAPSULE in 1 BOTTLE (66758-102-11)Marketed from Nov 1, 2024 |
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)
- Hycamtin
- Generic name (nonproprietary)
- topotecan
- Active ingredients
- Topotecan hydrochloride — 1 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 66758
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020981
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 66758-102_b23b46f5-c276-47f5-8bbd-940680b3f579SPL ID b23b46f5-c276-47f5-8bbd-940680b3f579SPL set ID b23b46f5-c276-47f5-8bbd-940680b3f579RxCUI 747193, 747195, 748738, 748740UNII 956S425ZCY
- Pharmacologic class
- Topoisomerase Inhibitor
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
N466758010211followed by a unit qualifier and the quantityPackage 66758-0102-11. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 66758-102
- What is NDC 66758-102?
- 66758-102 is the product NDC for Hycamtin (topotecan), Topotecan hydrochloride 1 mg/1 capsule, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hycamtin (Topotecan).
- What is the active ingredient?
- Topotecan hydrochloride.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 66758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hycamtin?
- 2 other product NDCs are listed under this name. See all Hycamtin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hycamtin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hycamtintopotecan | Topotecan hydrochloride .25 mg/1 | CapsuleOral | Sandoz Inc | 66758-101 | 66758-0101-11 |
| Hycamtintopotecan hydrochloride | Topotecan hydrochloride 4 mg/4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Novartis Pharmaceuticals Corporation | 0078-0674 | 00078-0674-61 |
Other NDCs under NDA 020981
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 |
|---|---|---|---|---|
| Hycamtintopotecan | Topotecan hydrochloride .25 mg/1 | CapsuleOral | Sandoz Inc | 66758-101 |