LEVEMIR
- Product NDC
- 50090-6391
- 11-digit product format
- 500906391
- Labeler code
- 50090
- Product ID
- 50090-6391_9736dfc4-160a-4df2-8524-4419fea3403b
- 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
- Substance
- INSULIN DETEMIR
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEVEMIR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN DETEMIR | 100 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4FT78T86XV |
| Rxcui | 847239, 847241 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6391-0 | LEVEMIR | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 24 |
| 50090-6391-0 | LEVEMIR | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6391 | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 24 | Current NDC, 2 package rows | 20230317_35e31793-9df4-4773-82b2-59678d8652bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6391-0 | 50090639100 | 5 SYRINGE, PLASTIC in 1 CARTON (50090-6391-0) / 3 mL in 1 SYRINGE, PLASTIC | 2023-03-09 | No | No | Historical |