topotecan
- Product NDC
- 25021-236
- 11-digit product format
- 250210236
- Labeler code
- 25021
- Product ID
- 25021-236_9a438a29-0a0f-44e6-978c-32d098c41047
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topotecan
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- NDA022453
- Marketing category
- NDA
- Marketing start
- 2014-12-15
- Marketing end
- 2021-01-31
- 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 | 25021-236 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 25021-236 | 25021-236-04 | 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 |
|---|
| N022453-001 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | | | 2012-12-20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| topotecan hydrochloride | ACTIVE INGREDIENT | 956S425ZCY | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 3 | |
| topotecan | ACTIVE MOIETY | 7M7YKX2N15 | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 3 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 3 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 3 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 3 | |
| tartaric acid | INACTIVE INGREDIENT | W4888I119H | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 3 | |