Levemir
- Product NDC
- 0169-6438
- 11-digit product format
- 001696438
- Labeler code
- 0169
- Product ID
- 0169-6438_40c85e9f-5e3e-4f53-a642-1ee982273108
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin detemir
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Novo Nordisk
- 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 table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-6438-10 | Levemir | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 30 |
| 0169-6438-10 | Levemir | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 30 |
| 0169-6438-90 | Levemir | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 30 |
| 0169-6438-97 | Levemir | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 30 |
| 0169-6438-98 | Levemir | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 30 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INSULIN DETEMIR | ACTIVE INGREDIENT | 4FT78T86XV | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| INSULIN DETEMIR | ACTIVE MOIETY | 4FT78T86XV | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| ZINC | INACTIVE INGREDIENT | J41CSQ7QDS | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-6438 | LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK] | 28 | Legacy NDC, 5 package rows | 20240605_d38d65c1-25bf-401d-9c7e-a2c3222da8af.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0169-6438-10 | 00169643810 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-6438-10) > 3 mL in 1 SYRINGE, PLASTIC | | 2013-10-31 | 0000-00-00 | No | No | Current |
| 0169-6438-90 | 00169643890 | 3 mL in 1 SYRINGE, PLASTIC | 3 ml | | | | | Historical |
| 0169-6438-97 | 00169643897 | 1 in 1 CARTON | | | | | | Historical |
| 0169-6438-98 | 00169643898 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-6438-98) > 3 mL in 1 SYRINGE, PLASTIC (0169-6438-90) | | 2013-10-31 | 0000-00-00 | No | No | Current |