TOPOTECAN HYDROCHLORIDE
- Product NDC
- 69097-262
- 11-digit product format
- 690970262
- Labeler code
- 69097
- Product ID
- 69097-262_4e757b90-6761-4586-914f-6bc194402399
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPOTECAN HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Cipla USA Inc.
- Application
- ANDA091199
- Marketing category
- ANDA
- Marketing start
- 2010-12-01
- 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
- 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 | 69097-262 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 69097-262 | 69097-262-67 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 69097-262 | 69097-262-68 | 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 |
|---|
| A091199-001 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE / INJECTION | AP | | 2010-12-01 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A091199-001 | AP |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-262-67 | 69097026267 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-262-67) > 4 mL in 1 VIAL, SINGLE-DOSE | 2010-12-01 | 0000-00-00 | No | No | Current |
| 69097-262-68 | 69097026268 | 5 VIAL, SINGLE-DOSE in 1 CARTON (69097-262-68) > 4 mL in 1 VIAL, SINGLE-DOSE | 2010-12-01 | 0000-00-00 | No | No | Current |