Topotecan Hydrochloride
- Product NDC
- 63323-762
- 11-digit product format
- 633230762
- Labeler code
- 63323
- Product ID
- 63323-762_7f91362f-6b55-4518-b034-b54aa5881204
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPOTECAN HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA091089
- Marketing category
- ANDA
- Marketing start
- 2010-11-30
- Substance
- TOPOTECAN HYDROCHLORIDE
- Active strength
- 4 mg/4mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topotecan Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 63323-762-10 | Topotecan Hydrochloride | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 15 |
| 63323-762-10 | Topotecan Hydrochloride | 4 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 4 | | 15 |
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 [FRESENIUS KABI USA, LLC] | 1 | |
| TOPOTECAN | ACTIVE MOIETY | 7M7YKX2N15 | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-762 | TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240724_b6019088-cd94-43b4-b5ce-ba20b6b8021e.zip |
| 63323-762 | TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, Legacy NDC | 20210626_b094e6ba-7cf6-4fb8-8683-73d324650dd3.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 |
|---|
| 63323-762-10 | 63323076210 | 1 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL | 1 vial | 2010-11-30 | 0000-00-00 | No | No | Current |
| 63323-762-94 | 63323076294 | 1 VIAL in 1 BOX (63323-762-94) > 4 mL in 1 VIAL | 1 vial | 2010-11-30 | 0000-00-00 | No | No | Current |