Insulin Degludec
- Product NDC
- 73070-400
- 11-digit product format
- 730700400
- Labeler code
- 73070
- Product ID
- 73070-400_c1be283d-4b1d-4996-b2a7-4488dbff3037
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin degludec
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Novo Nordisk Pharma, Inc.
- Application
- BLA203314
- Marketing category
- BLA
- Marketing start
- 2022-07-01
- Marketing end
- 2027-08-31
- 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
- Insulin Degludec
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN DEGLUDEC | 100 U/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 54Q18076QB |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73070-400-11 | Insulin Degludec | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 1 |
| 73070-400-11 | Insulin Degludec | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73070-400 | INSULIN DEGLUDEC INJECTION, SOLUTION [NOVO NORDISK PHARMA, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220717_c1be283d-4b1d-4996-b2a7-4488dbff3037.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 |
|---|
| 73070-400-11 | 73070040011 | 1 VIAL, GLASS in 1 CARTON (73070-400-11) / 10 mL in 1 VIAL, GLASS | 2022-07-01 | 0000-00-00 | No | No | Current |