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NDC 16729-0243-31 Topotecan 1 mg/mL Details
Topotecan 1 mg/mL
Topotecan is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is TOPOTECAN.
MedlinePlus Drug Summary
Topotecan injection is used to treat ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed) and small cell lung cancer (a type of cancer that begins in the lungs) that have spread and did not improve after treatment with other medications. It is also used together with other medications to treat cervical cancer (cancer that begins in the opening of the uterus [womb]) that has not improved or has come back after other treatments. Topotecan is in a class of medications called topoisomerase type I inhibitors. It works by killing cancer cells.
Related Packages: 16729-0243-31Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Topotecan Injection
Product Information
| NDC | 16729-0243 |
|---|---|
| Product ID | 16729-243_0c601675-1499-39ec-e063-6394a90ac744 |
| Associated GPIs | 21550080102020 |
| GCN Sequence Number | 068854 |
| GCN Sequence Number Description | topotecan HCl VIAL 1 MG/ML(1) INTRAVEN |
| HIC3 | V3E |
| HIC3 Description | ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS |
| GCN | 31739 |
| HICL Sequence Number | 011381 |
| HICL Sequence Number Description | TOPOTECAN HCL |
| Brand/Generic | Generic |
| Proprietary Name | Topotecan |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Topotecan |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | TOPOTECAN |
| Labeler Name | Accord Healthcare Inc. |
| Pharmaceutical Class | Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204406 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16729-0243-31 (16729024331)
| NDC Package Code | 16729-243-31 |
|---|---|
| Billing NDC | 16729024331 |
| Package | 1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2020-07-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |