Topotecan
- Product NDC
- 0703-4714
- 11-digit product format
- 007034714
- Labeler code
- 0703
- Product ID
- 0703-4714_ecf75b05-d006-403c-a5b6-c64c632e6755
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topotecan
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Teva Parenteral Medicines, Inc.
- Application
- NDA022453
- Marketing category
- NDA
- Marketing start
- 2013-05-21
- Marketing end
- 0000-00-00
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 0703-4714 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0703-4714 | 0703-4714-01 | 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 |
|---|
| 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 [TEVA PARENTERAL MEDICINES, INC.] | 4 | |
| TOPOTECAN | ACTIVE MOIETY | 7M7YKX2N15 | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 4 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 4 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0703-4714-01 | 00703471401 | 1 VIAL, SINGLE-USE in 1 CARTON (0703-4714-01) > 4 mL in 1 VIAL, SINGLE-USE (0703-4714-71) | 2013-05-21 | 0000-00-00 | No | No | Current |