Cardiolite

Product NDC: 87333-001
11-digit product format: 873330001
Labeler code: 87333
Product ID: 87333-001_258f6ed0-be7d-4c94-b737-fd822eb58c6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: SHINE SPECT USA, LLC
Application: NDA019785
Marketing category: NDA
Marketing start: 2026-09-10
Substance: TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
Active strength: 1 mg/mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019785-001	CARDIOLITE	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21
N019785-003	MIRALUMA	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE / INJECTION			1997-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019785-001	AP

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019785-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019785-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019785-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019785-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019785-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019785-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019785-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019785-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019785-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019785-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019785-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019785-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019785-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019785-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019785-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019785-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019785-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019785-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019785-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019785-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019785-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019785-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019785-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019785-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019785-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019785-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019785-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019785-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019785-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019785-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019785-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019785-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019785-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019785-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019785-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019785-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019785-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019785-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019785-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019785-001	AP	1	`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: Cardiolite
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N6OU7HJ70P	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
773b6729-2a74-49e7-9215-ca70da3b854c	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	SHINE SPECT USA, LLC	773b6729-2a74-49e7-9215-ca70da3b854c	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019785 application number: NDA019785 ndc (product): 87333-001
Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	49662def-2fb9-47b2-8467-ca56f6006167	2022-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019785 application number: NDA019785
Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	8c03a854-185a-45d7-883f-9f87e4750181	2022-11-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019785 application number: NDA019785

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N6OU7HJ70P	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	103694-84-4	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87333-001-20	87333000120	20 VIAL in 1 BOX (87333-001-20) / 5 mL in 1 VIAL	20 vial	2026-09-10	No	No	Current
87333-001-55	87333000155	5 VIAL in 1 BOX (87333-001-55) / 5 mL in 1 VIAL	5 vial	2026-09-10	No	No	Current

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