| Product NDC: | 54868-5883 |
| Proprietary Name: | Levemir |
| Non Proprietary Name: | insulin detemir |
| Active Ingredient(s): | 14.2 mg/mL & nbsp; insulin detemir |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-5883 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021536 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080331 |
| Package NDC: | 54868-5883-0 |
| Package Description: | 5 SYRINGE, PLASTIC in 1 CARTON (54868-5883-0) > 3 mL in 1 SYRINGE, PLASTIC |
| NDC Code | 54868-5883-0 |
| Proprietary Name | Levemir |
| Package Description | 5 SYRINGE, PLASTIC in 1 CARTON (54868-5883-0) > 3 mL in 1 SYRINGE, PLASTIC |
| Product NDC | 54868-5883 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | insulin detemir |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20080331 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | INSULIN DETEMIR |
| Strength Number | 14.2 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Insulin [Chemical/Ingredient],Insulin Analog [EPC] |