Tresiba
- Product NDC
- 50090-3491
- 11-digit product format
- 500903491
- Labeler code
- 50090
- Product ID
- 50090-3491_ee96b54f-5204-4b1b-8e9c-593f56045b66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin degludec
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- Application
- BLA203314
- Marketing category
- BLA
- Marketing start
- 2015-09-25
- Substance
- INSULIN DEGLUDEC
- Active strength
- 200 U/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tresiba
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN DEGLUDEC | 200 U/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 54Q18076QB |
| Rxcui | 1670021, 1670023 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3491-0 | Tresiba | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 11 |
| 50090-3491-0 | Tresiba | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3491 | TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 11 | Current NDC, Legacy NDC, 2 package rows | 20231213_84197351-cb71-4282-8217-13103404a2b4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-3491-0 | 50090349100 | 3 SYRINGE, PLASTIC in 1 CARTON (50090-3491-0) / 3 mL in 1 SYRINGE, PLASTIC | 2018-06-20 | 0000-00-00 | No | No | Current |