| Product NDC: | 47584-001 |
| Proprietary Name: | Fludeoxyglucose |
| Non Proprietary Name: | Fludeoxyglucose F18 |
| Active Ingredient(s): | 500 mCi/mL & nbsp; Fludeoxyglucose F18 |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 47584-001 |
| Labeler Name: | Cyclotron Partners LP dba Cyclotope |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA203665 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20111208 |
| Package NDC: | 47584-001-01 |
| Package Description: | 16 mL in 1 VIAL, GLASS (47584-001-01) |
| NDC Code | 47584-001-01 |
| Proprietary Name | Fludeoxyglucose |
| Package Description | 16 mL in 1 VIAL, GLASS (47584-001-01) |
| Product NDC | 47584-001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Fludeoxyglucose F18 |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20111208 |
| Marketing Category Name | ANDA |
| Labeler Name | Cyclotron Partners LP dba Cyclotope |
| Substance Name | FLUDEOXYGLUCOSE F-18 |
| Strength Number | 500 |
| Strength Unit | mCi/mL |
| Pharmaceutical Classes | Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] |