| Product NDC: | 63323-365 |
| Proprietary Name: | Octreotide |
| Non Proprietary Name: | OCTREOTIDE ACETATE |
| Active Ingredient(s): | 50 ug/mL & nbsp; OCTREOTIDE ACETATE |
| Administration Route(s): | INTRAVENOUS; SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-365 |
| Labeler Name: | Fresenius Kabi USA, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077457 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20060314 |
| Package NDC: | 63323-365-01 |
| Package Description: | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-365-01) > 1 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 63323-365-01 |
| Proprietary Name | Octreotide |
| Package Description | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-365-01) > 1 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 63323-365 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | OCTREOTIDE ACETATE |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS; SUBCUTANEOUS |
| Start Marketing Date | 20060314 |
| Marketing Category Name | ANDA |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | OCTREOTIDE ACETATE |
| Strength Number | 50 |
| Strength Unit | ug/mL |
| Pharmaceutical Classes | Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] |