Temsirolimus
- Product NDC
- 72611-785
- 11-digit product format
- 726110785
- Labeler code
- 72611
- Product ID
- 72611-785_b2939aa0-0685-5031-41aa-3ecea4025e89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temsirolimus Injection
- Dosage form
- KIT
- Labeler
- Almaject, Inc.
- Application
- ANDA207383
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- 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 |
|---|
| 72611-780-01 | Temsirolimus | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 1 mL | 25 mg in 1mL | 6 |
| 72611-785-02 | Temsirolimus | 1 in 1 CARTON | KIT | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72611-785 | TEMSIROLIMUS (TEMSIROLIMUS INJECTION) KIT [ALMAJECT, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240412_a1f129ff-c0a4-ede7-ae9c-7a3cfa01fe12.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 |
|---|
| 72611-780-01 | 72611078001 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 72611-785-02 | 72611078502 | 1 KIT in 1 CARTON (72611-785-02) * 1.8 mL in 1 VIAL, SINGLE-DOSE (72611-782-01) * 1 mL in 1 VIAL, SINGLE-DOSE (72611-780-01) | 1 kit | 2020-05-08 | 0000-00-00 | No | No | Current |