| Product NDC: | 52125-416 |
| Proprietary Name: | Lantus |
| Non Proprietary Name: | insulin glargine |
| Active Ingredient(s): | 100 [iU]/mL & nbsp; insulin glargine |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52125-416 |
| Labeler Name: | REMEDYREPACK INC. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021081 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130612 |
| Package NDC: | 52125-416-01 |
| Package Description: | 10 mL in 1 VIAL, GLASS (52125-416-01) |
| NDC Code | 52125-416-01 |
| Proprietary Name | Lantus |
| Package Description | 10 mL in 1 VIAL, GLASS (52125-416-01) |
| Product NDC | 52125-416 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | insulin glargine |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20130612 |
| Marketing Category Name | NDA |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | INSULIN GLARGINE |
| Strength Number | 100 |
| Strength Unit | [iU]/mL |
| Pharmaceutical Classes | Insulin [Chemical/Ingredient],Insulin Analog [EPC] |