Home NDC 54828-001-30 Neuraceq
Product NDC 54828-001
Requested package NDC 54828-001-30
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204677-001 NEURACEQ FLORBETABEN F-18 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 N204677-001 9308284 2032-07-14 Drug product 2025-07-31
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204677-001 NEURACEQ 1.4-135mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204677-001 NEURACEQ 30ML (1.4-135mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-19 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 45 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204677-001 9308284 2032-07-14 Drug product 2025-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204677-001 9308284 2032-07-14 Drug product 2025-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204677-001 9308284 2032-07-14 Drug product 2025-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204677-001 7807135 2029-03-18 U-1497 Drug substance, Drug product 2014-04-04 3a93d1ddd44b…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N204677-001 NCE 2019-03-21 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N204677-001 NCE 2019-03-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204677-001 NCE 2019-03-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204677-001 NCE 2019-03-21 ea99ee380514…
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TLA7312TOI Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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