HYCAMTIN
- Product NDC
- 0078-0674
- 11-digit product format
- 000780674
- Labeler code
- 0078
- Product ID
- 0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topotecan hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA020671
- Marketing category
- NDA
- Marketing start
- 2016-12-21
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- 4 mg/4mL
- 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 | 4 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 956S425ZCY |
| Rxcui | 637550, 1799416 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0674-61 | HYCAMTIN | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 4 | | 8 |
| 0078-0674-61 | HYCAMTIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0674 | HYCAMTIN (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 8 | Current NDC, Legacy NDC, 2 package rows | 20220709_eeee060c-a9ec-423e-a374-8484009f8524.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0674-61 | 00078067461 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE | 2016-12-21 | 0000-00-00 | No | No | Current |