Levemir
- Product NDC
- 50090-1475
- 11-digit product format
- 500901475
- Labeler code
- 50090
- Product ID
- 50090-1475_2c52048f-d704-426f-9737-104af6f013c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin detemir
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- Application
- BLA021536
- Marketing category
- BLA
- Marketing start
- 2013-10-31
- Marketing end
- 0000-00-00
- Substance
- INSULIN DETEMIR
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1475-0 | Levemir | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 24 | |
| 50090-1475-0 | Levemir | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1475-0 | ML - Milliliter | 50090-1475 | 8cd1ea72-842d-40fa-881a-20c57935f029 | 1 | 2018-10-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1475 | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 24 | Legacy NDC, 2 package rows | 20241010_82192527-99aa-4b53-8ce9-9173668d309c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 847239 | insulin detemir 100 UNT/ML in 3 ML Pen Injector | PSN | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 484322 | insulin detemir 100 UNT/ML Injectable Solution | PSN | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 847241 | Levemir 100 UNT/ML in 3 ML Pen Injector | PSN | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 616238 | Levemir 100 UNT/ML Injectable Solution | PSN | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 847241 | 3 ML insulin detemir 100 UNT/ML Pen Injector [Levemir] | SBD | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 616238 | insulin detemir 100 UNT/ML Injectable Solution [Levemir] | SBD | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 847239 | 3 ML insulin detemir 100 UNT/ML Pen Injector | SCD | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 484322 | insulin detemir 100 UNT/ML Injectable Solution | SCD | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 847241 | 3 ML Levemir 100 UNT/ML Pen Injector | SY | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 484322 | insulin analog, detemir 100 UNT/ML Injectable Solution | SY | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 847241 | Levemir 100 UNT/ML 3 ML FlexPen | SY | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 847241 | Levemir 100 UNT/ML 3 ML FlexTouch | SY | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 847241 | Levemir 100 UNT/ML 3 ML PenFill | SY | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 616238 | Levemir 100 UNT/ML Injectable Solution | SY | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
| 616238 | Levemir 14.2 MG/ML Injectable Solution | SY | 82192527-99aa-4b53-8ce9-9173668d309c | 24 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-1475-0 | 50090147500 | 5 SYRINGE, PLASTIC in 1 CARTON (50090-1475-0) > 3 mL in 1 SYRINGE, PLASTIC | 2014-11-28 | 0000-00-00 | No | No | Current |