TOPOTECAN
- Product NDC
- 67457-662
- 11-digit product format
- 674570662
- Labeler code
- 67457
- Product ID
- 67457-662_bad69ff7-d8b4-4436-a7f7-cbf49488c5e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPOTECAN
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA206074
- Marketing category
- ANDA
- Marketing start
- 2018-04-09
- Marketing end
- 2022-02-28
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 67457-662 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 67457-662 | 67457-662-05 | 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 |
|---|
| A206074-001 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | | | 2017-11-24 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-662-05 | 67457066205 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-662-05) > 4 mL in 1 VIAL, SINGLE-DOSE | 2018-04-09 | 0000-00-00 | No | No | Current |