Topotecan Hydrochloride
- Product NDC
- 55390-370
- 11-digit product format
- 553900370
- Labeler code
- 55390
- Product ID
- 55390-370_654d0d44-73a6-baa4-78ec-8fa492237dab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topotecan Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Bedford Laboratories
- Application
- ANDA201191
- Marketing category
- ANDA
- Marketing start
- 2011-04-18
- 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
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 |
|---|
| 55390-370-10 | Topotecan Hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 55390-370-10 | Topotecan Hydrochloride | 4 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 4 | | 5 |
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 [BEDFORD LABORATORIES ] | 3 | |
| Topotecan | ACTIVE MOIETY | 7M7YKX2N15 | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] | 3 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] | 3 | |
| Mannitol | INACTIVE INGREDIENT | 3OWL53L36A | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] | 3 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] | 3 | |
| Tartaric Acid | INACTIVE INGREDIENT | W4888I119H | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55390-370 | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] | 5 | Legacy NDC, 2 package rows | 20181211_a439bf07-53db-0352-846a-99d9da772f9b.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 |
|---|
| 55390-370-10 | 55390037010 | 1 VIAL in 1 CARTON (55390-370-10) > 4 mL in 1 VIAL | 1 vial | 2020-12-01 | 0000-00-00 | No | No | Current |