HYCAMTIN
- Product NDC
- 66758-101
- 11-digit product format
- 667580101
- Labeler code
- 66758
- Product ID
- 66758-101_b23b46f5-c276-47f5-8bbd-940680b3f579
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topotecan
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- NDA020981
- Marketing category
- NDA
- Marketing start
- 2017-07-07
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- .25 mg/1
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 956S425ZCY | TOPOTECAN HYDROCHLORIDE | 119413-54-6 | TOPOTECAN HYDROCHLORIDE |
| 7M7YKX2N15 | TOPOTECAN | 123948-87-8 | topotecan |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66758-101-11 | 66758010111 | 10 CAPSULE in 1 BOTTLE (66758-101-11) | 10 capsule | 2025-01-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| HYCAMTIN | Sandoz Inc | 2023-09-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |