Fludeoxyglucose F18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sofie Co. Dba Sofie. The primary component is Fludeoxyglucose F-18.
| Product ID | 49609-001_a52a159d-f3e3-3f7a-e053-2995a90a038f |
| NDC | 49609-001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fludeoxyglucose F18 |
| Generic Name | Fludeoxyglucose F18 |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2011-12-08 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203665 |
| Labeler Name | SOFIE Co. dba SOFIE |
| Substance Name | FLUDEOXYGLUCOSE F-18 |
| Active Ingredient Strength | 500 mCi/mL |
| Pharm Classes | Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2011-12-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203665 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-12-08 |
| Ingredient | Strength |
|---|---|
| FLUDEOXYGLUCOSE F-18 | 500 mCi/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13267-123 | Fludeoxyglucose F18 | Fludeoxyglucose F18 |
| 24275-0185 | Fludeoxyglucose F18 | Fludeoxyglucose F18 |
| 24562-003 | Fludeoxyglucose F18 | Fludeoxyglucose F-18 |
| 44338-001 | Fludeoxyglucose F18 | Fludeoxyglucose F-18 |
| 51760-001 | Fludeoxyglucose F18 | Fludeoxyglucose F18 |
| 69815-754 | Fludeoxyglucose F18 | Fludeoxyglucose F18 |
| 69864-001 | Fludeoxyglucose F18 | Fludeoxyglucose F18 |
| 81365-001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 |
| 24562-001 | Fludeoxyglucose F18 | Fludeoxyglucose F18 |
| 13267-234 | Fludeoxyglucose | Fludeoxyglucose F18 |
| 47584-001 | Fludeoxyglucose | Fludeoxyglucose F18 |
| 49609-001 | Fludeoxyglucose | Fludeoxyglucose F18 |
| 60215-411 | Fludeoxyglucose | Fludeoxyglucose F18 |
| 62072-008 | Fludeoxyglucose | Fludeoxyglucose F18 |
| 69587-001 | Fludeoxyglucose | Fludeoxyglucose F18 |
| 76326-001 | Fludeoxyglucose | Fludeoxyglucose F18 |
| 76451-118 | Fludeoxyglucose | Fludeoxyglucose F18 |