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
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019785-001 | CARDIOLITE | N/A | INJECTABLE / INJECTION | AP | RLD, RS | 1990-12-21 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N019785-003 | MIRALUMA | N/A | INJECTABLE / INJECTION | 1997-05-23 | c2088c7a36db… | ||
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N019785-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N019785-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019785-001 | AP | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019785-001 | AP | 1 | a50c72e98297… |
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 |
|---|---|
| TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE | 1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N6OU7HJ70P | Internal UNII lookup |
Harmonized SPL set identifiers#
| 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.
| 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 | 019785 NDA019785 87333-001 |
| Cardiolite | TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE | Lantheus Medical Imaging, Inc. | 49662def-2fb9-47b2-8467-ca56f6006167 | 2022-12-06 | Warnings, Adverse reactions | 019785 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 | 019785 NDA019785 |
Packages#
| 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 |