Topotecan
- Product NDC
- 71288-127
- 11-digit product format
- 712880127
- Labeler code
- 71288
- Product ID
- 71288-127_06f2245d-e8d3-4436-bcfb-6df6123e8119
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topotecan Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA201166
- Marketing category
- ANDA
- Marketing start
- 2019-09-02
- Marketing end
- 0000-00-00
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- 4 mg/15mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-127-15 | Topotecan | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 71288-127-15 | Topotecan | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 15 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-127 | TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 2 | Legacy NDC, 2 package rows | 20200107_207ee628-1a7a-4949-bab2-07b9d79b72a3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-127-15 | 71288012715 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-127-15) > 15 mL in 1 VIAL, SINGLE-DOSE | 2019-09-02 | 0000-00-00 | No | No | Current |