TRESIBA
- Product NDC
- 50090-7077
- 11-digit product format
- 500907077
- Labeler code
- 50090
- Product ID
- 50090-7077_cc399f8e-7e57-48bd-993c-2104a4b1acf4
- 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
- 100 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 | 100 U/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 54Q18076QB |
| Rxcui | 1670011, 1670016 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7077-0 | TRESIBA | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 1 |
| 50090-7077-0 | TRESIBA | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7077 | TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20240203_afb63b26-5f28-4679-8a8b-5933ddf77fdc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7077-0 | 50090707700 | 5 SYRINGE, PLASTIC in 1 CARTON (50090-7077-0) / 3 mL in 1 SYRINGE, PLASTIC | 2024-01-29 | No | No | Current |