Topotecan
- Product NDC
- 50742-404
- 11-digit product format
- 507420404
- Labeler code
- 50742
- Product ID
- 50742-404_97cb281e-9fae-44b4-acdb-38ce71f46baf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topotecan
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA206962
- Marketing category
- ANDA
- Marketing start
- 2016-12-07
- Marketing end
- 0000-00-00
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- 4 mg/4mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 50742-404 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 50742-404 | 50742-404-01 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A206962-001 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE / INJECTION | AP | | 2016-11-30 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A206962-001 | AP |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50742-404-01 | 50742040401 | 4 mL in 1 VIAL (50742-404-01) | 4 ml | 2016-12-07 | 0000-00-00 | No | No | Current |