Home NDC 54828-001 Neuraceq
Product NDC 54828-001
11-digit product format 548280001
Labeler code 54828
Product ID 54828-001_4bcfe123-9c5b-2f90-e063-6294a90aaa46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Florbetaben F 18
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Lantheus Biosciences Ltd.
Application NDA204677
Marketing category NDA
Marketing start 2014-03-20
Substance FLORBETABEN F-18
Active strength 135 mCi/mL
Pharmacologic classes Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Neuraceq
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLORBETABEN F-18 135 mCi/mL
Harmonized Identifiers# Field, Values table Field Values Unii TLA7312TOI
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54828-001-30 Neuraceq 1 in 1 CONTAINER INJECTION, SOLUTION 1 41 54828-001-30 Neuraceq 30 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 30 41 54828-001-50 Neuraceq 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 41 54828-001-50 Neuraceq 1 in 1 CONTAINER INJECTION, SOLUTION 1 41
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLORBETABEN F-18 ACTIVE INGREDIENT TLA7312TOI NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [PIRAMAL IMAGING, SA] 3 FLORBETABEN F-18 ACTIVE MOIETY TLA7312TOI NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [PIRAMAL IMAGING, SA] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [PIRAMAL IMAGING, SA] 3 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [PIRAMAL IMAGING, SA] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [PIRAMAL IMAGING, SA] 3 SODIUM ASCORBATE INACTIVE INGREDIENT S033EH8359 NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [PIRAMAL IMAGING, SA] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54828-001 NEURACEQ (FLORBETABEN F 18) INJECTION, SOLUTION [LIFE MOLECULAR IMAGING, LTD] 39 Current NDC, Legacy NDC, 4 package rows 20250429_b0915068-cfd4-4d72-b9f8-7e31fe83cd1e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54828-001-30 54828000130 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-30) > 30 mL in 1 VIAL, MULTI-DOSE 2014-03-20 0000-00-00 No No Current 54828-001-50 54828000150 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE 2022-06-13 0000-00-00 No No Current