Home NDC 11994-006 NEUROLITE
Product NDC 11994-006
11-digit product format 119940006
Labeler code 11994
Product ID 11994-006_6a6da20d-b33c-4e9e-98da-8d9b7cc963ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bicisate dihydrochloride
Dosage form KIT
Labeler Lantheus Medical Imaging, Inc.
Application NDA020256
Marketing category NDA
Marketing start 1994-11-23
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020256-001 NEUROLITE TECHNETIUM TC-99M BICISATE KIT N/A INJECTABLE / INJECTION RLD, RS 1994-11-23
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 · 42 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 2026-08-18 06:07:40 2026-07 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020256-001 NEUROLITE N/A INJECTABLE / INJECTION RLD, RS 1994-11-23 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base NEUROLITE
Listing expiration 2026-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11994-006 NEUROLITE (BICISATE DIHYDROCHLORIDE) KIT [LANTHEUS MEDICAL IMAGING, INC.] 12 Current NDC, Legacy NDC, 5 package rows 20221129_f9adbcd5-1ac1-42d8-b18a-a76c9204014c.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NEUROLITE BICISATE DIHYDROCHLORIDE Lantheus Medical Imaging, Inc. f9adbcd5-1ac1-42d8-b18a-a76c9204014c 2022-11-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 020256 application number: NDA020256 ndc (product): 11994-006
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11994-002-01 11994000201 1 in 1 VIAL Historical 11994-006-02 11994000602 2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) 2 kit 1994-11-23 0000-00-00 No No Current 11994-006-05 11994000605 5 KIT in 1 PACKAGE, COMBINATION (11994-006-05) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) 5 kit 1994-11-23 0000-00-00 No No Current