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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYCAMTIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPOTECAN HYDROCHLORIDE | .25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 956S425ZCY |
| Rxcui | 747193, 747195, 748738, 748740 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66758-101-11 | HYCAMTIN | 10 in 1 BOTTLE | CAPSULE | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66758-101 | HYCAMTIN (TOPOTECAN) CAPSULE [SANDOZ INC] | 1 | Current NDC, 1 package rows | 20241031_b23b46f5-c276-47f5-8bbd-940680b3f579.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |