Temsirolimus
- Product NDC
- 16729-223
- 11-digit product format
- 167290223
- Labeler code
- 16729
- Product ID
- 16729-223_116814b6-e438-8a45-e063-6394a90a9fad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temsirolimus
- Dosage form
- KIT
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA203153
- Marketing category
- ANDA
- Marketing start
- 2018-08-13
- 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 |
|---|
| 16729-221-30 | Temsirolimus | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 1 mL | 25 mg in 1mL | 3 |
| 16729-223-61 | Temsirolimus | 1 in 1 KIT | KIT | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-223 | TEMSIROLIMUS KIT [ACCORD HEALTHCARE INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240216_ae8d2354-7ddb-41b8-9d55-77c84782b18f.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 |
|---|
| 16729-221-30 | 16729022130 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 16729-223-61 | 16729022361 | 1 KIT in 1 KIT (16729-223-61) * 1 mL in 1 VIAL, SINGLE-DOSE (16729-221-30) * 1.8 mL in 1 VIAL, SINGLE-DOSE (16729-222-30) | 1 kit | 2018-08-13 | 0000-00-00 | No | No | Current |