Tresiba
- Product NDC
- 0169-2662
- 11-digit product format
- 001692662
- Labeler code
- 0169
- Product ID
- 0169-2662_e5571110-ca7e-4fcc-88a8-9f1d0104c508
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin degludec
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Novo Nordisk
- Application
- BLA203314
- Marketing category
- BLA
- Marketing start
- 2018-11-21
- 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, 1670021, 1670023, 2107520, 2107522 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-2662-11 | Tresiba | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 14 |
| 0169-2662-11 | Tresiba | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 14 |
| 0169-2662-90 | Tresiba | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 14 |
| 0169-2662-90 | Tresiba | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INSULIN DEGLUDEC | ACTIVE INGREDIENT | 54Q18076QB | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| INSULIN DEGLUDEC | ACTIVE MOIETY | 54Q18076QB | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
| ZINC | INACTIVE INGREDIENT | J41CSQ7QDS | TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-2662 | TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [NOVO NORDISK] | 14 | Current NDC, Legacy NDC, 4 package rows | 20220720_456c5e87-3dfd-46fa-8ac0-c6128d4c97c6.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 |
|---|
| 0169-2662-11 | 00169266211 | 1 VIAL, GLASS in 1 CARTON (0169-2662-11) / 10 mL in 1 VIAL, GLASS | 2019-02-05 | 0000-00-00 | No | No | Current |
| 0169-2662-90 | 00169266290 | 1 VIAL, GLASS in 1 CARTON (0169-2662-90) / 10 mL in 1 VIAL, GLASS | 2019-02-05 | 0000-00-00 | No | No | Current |