Temsirolimus
- Product NDC
- 65219-200
- 11-digit product format
- 652190200
- Labeler code
- 65219
- Product ID
- 65219-200_2b33d5f1-198e-41ef-ac78-ccfd27fc137a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temsirolimus
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA207383
- Marketing category
- ANDA
- Marketing start
- 2020-11-20
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Temsirolimus
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 722289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-200-05 | Temsirolimus | 1 in 1 KIT | KIT | 1 | | 2 |
| 65219-205-05 | Temsirolimus | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 1 mL | 25 mg in 1mL | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-200 | TEMSIROLIMUS KIT [FRESENIUS KABI USA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20201120_1c207bed-10e3-46f0-ad2c-69d5e5c97736.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 |
|---|
| 65219-200-05 | 65219020005 | 1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05) | 1 kit | 2020-11-20 | 0000-00-00 | No | No | Current |
| 65219-205-05 | 65219020505 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |