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NDC 52768-0001-50 Fludeoxyglucose F-18 500 mCi/mL Details
Fludeoxyglucose F-18 500 mCi/mL
Fludeoxyglucose F-18 is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Precision Nuclear, LLC. The primary component is FLUDEOXYGLUCOSE F-18.
Product Information
| NDC | 52768-0001 |
|---|---|
| Product ID | 52768-001_8b8dbff0-19ba-4967-893e-6451685dc851 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Fludeoxyglucose F-18 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | FLUDEOXYGLUCOSE F-18 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mCi/mL |
| Substance Name | FLUDEOXYGLUCOSE F-18 |
| Labeler Name | Precision Nuclear, LLC |
| Pharmaceutical Class | Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204546 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52768-0001-50 (52768000150)
| NDC Package Code | 52768-001-50 |
|---|---|
| Billing NDC | 52768000150 |
| Package | 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50) / 50 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2010-10-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |