topotecan hydrochloride
- Product NDC
- 16729-151
- 11-digit product format
- 167290151
- Labeler code
- 16729
- Product ID
- 16729-151_23a75b4a-a836-a01d-e063-6394a90a67b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topotecan hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA202351
- Marketing category
- ANDA
- Marketing start
- 2013-07-23
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- 4 mg/4mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- topotecan hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPOTECAN HYDROCHLORIDE | 4 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 956S425ZCY |
| Rxcui | 1799416 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-151-31 | topotecan hydrochloride | 1 in 1 PACKAGE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 10 |
| 16729-151-31 | topotecan hydrochloride | 4 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 4 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPOTECAN HYDROCHLORIDE | ACTIVE INGREDIENT | 956S425ZCY | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 6 | |
| TOPOTECAN | ACTIVE MOIETY | 7M7YKX2N15 | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 6 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-151 | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241006_729b2b22-1344-44f3-b614-14f6ec3c263e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-151-31 | 16729015131 | 1 VIAL in 1 PACKAGE (16729-151-31) / 4 mL in 1 VIAL | 1 vial | 2013-07-23 | 0000-00-00 | No | No | Current |