NEUROLITE

Product NDC: 87333-006
11-digit product format: 873330006
Labeler code: 87333
Product ID: 87333-006_723b95b6-fc1e-4f5f-9102-5fcaa4ea4400
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bicisate dihydrochloride
Dosage form: KIT
Labeler: SHINE SPECT USA, LLC
Application: NDA020256
Marketing category: NDA
Marketing start: 2026-09-10
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020256-001	NEUROLITE	N/A	INJECTABLE / INJECTION	RLD, RS	1994-11-23	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: NEUROLITE
Listing expiration: 2027-12-31

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e2c9efae-4e57-4f05-ac72-5443dea03f38	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NEUROLITE	BICISATE DIHYDROCHLORIDE	SHINE SPECT USA, LLC	e2c9efae-4e57-4f05-ac72-5443dea03f38	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020256 application number: NDA020256 ndc (product): 87333-006
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B005P07V07	BICISATE DIHYDROCHLORIDE	14344-58-2	Bicisate dihydrochloride

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87333-006-02	87333000602	2 KIT in 1 PACKAGE, COMBINATION (87333-006-02) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (87333-002-01) * 1 mL in 1 VIAL (87333-004-01)	2 kit	2026-09-10	No	No	Current
87333-006-05	87333000605	5 KIT in 1 PACKAGE, COMBINATION (87333-006-05) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (87333-002-01) * 1 mL in 1 VIAL (87333-004-01)	5 kit	2026-09-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEUROLITE	SHINE SPECT USA, LLC \| Jubilant HollisterStier	2026-09-10	HUMAN PRESCRIPTION DRUG LABEL	2