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NDC 54828-0001-50 Neuraceq 135 mCi/mL Details
Neuraceq 135 mCi/mL
Neuraceq is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Life Molecular Imaging, Ltd. The primary component is FLORBETABEN F-18.
Product Information
| NDC | 54828-0001 |
|---|---|
| Product ID | 54828-001_eb884bdb-3ff8-4765-8ee8-550a583c4bac |
| Associated GPIs | 94352520002030 |
| GCN Sequence Number | 072183 |
| GCN Sequence Number Description | florbetaben F-18 VIAL 8.1 MCI INTRAVEN |
| HIC3 | H1Y |
| HIC3 Description | DIAGNOSTIC RADIOPHARM - AMYLOID/TAU IMAGING |
| GCN | 36304 |
| HICL Sequence Number | 041025 |
| HICL Sequence Number Description | FLORBETABEN F-18 |
| Brand/Generic | Brand |
| Proprietary Name | Neuraceq |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | florbetaben F 18 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 135 |
| Active Ingredient Units | mCi/mL |
| Substance Name | FLORBETABEN F-18 |
| Labeler Name | Life Molecular Imaging, Ltd |
| Pharmaceutical Class | Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA204677 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 54828-0001-50 (54828000150)
| NDC Package Code | 54828-001-50 |
|---|---|
| Billing NDC | 54828000150 |
| Package | 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2022-06-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |