Cardiolite
- Product NDC
- 11994-001
- 11-digit product format
- 119940001
- Labeler code
- 11994
- Product ID
- 11994-001_d515f49a-8eb4-42f3-a7ee-1634a4804ca5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Lantheus Medical Imaging, Inc.
- Application
- NDA019785
- Marketing category
- NDA
- Marketing start
- 1990-12-20
- Substance
- TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
- Active strength
- 1 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cardiolite
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N6OU7HJ70P |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11994-001-20 | Cardiolite | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 19 |
| 11994-001-20 | Cardiolite | 20 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 20 | | 19 |
| 11994-001-55 | Cardiolite | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 19 |
| 11994-001-55 | Cardiolite | 5 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 5 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE | ACTIVE INGREDIENT | N6OU7HJ70P | CARDIOLITE (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] | 13 | |
| TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE | ACTIVE MOIETY | N6OU7HJ70P | CARDIOLITE (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] | 13 | |
| CYSTEINE HYDROCHLORIDE | INACTIVE INGREDIENT | ZT934N0X4W | CARDIOLITE (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] | 13 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CARDIOLITE (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] | 13 | |
| STANNOUS CHLORIDE | INACTIVE INGREDIENT | 1BQV3749L5 | CARDIOLITE (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] | 13 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | CARDIOLITE (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11994-001 | CARDIOLITE (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] | 19 | Current NDC, Legacy NDC, 4 package rows | 20221208_49662def-2fb9-47b2-8467-ca56f6006167.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11994-001-00 | 11994000100 | 5 mL in 1 SYRINGE (11994-001-00) | 5 ml | 1990-12-20 | 0000-00-00 | No | No | Current |
| 11994-001-20 | 11994000120 | 20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL | 20 vial | 2008-02-28 | 0000-00-00 | No | No | Current |
| 11994-001-52 | 11994000152 | 2 VIAL in 1 BOX (11994-001-52) > 5 mL in 1 VIAL | 2 vial | 1990-12-20 | 0000-00-00 | No | No | Current |
| 11994-001-55 | 11994000155 | 5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL | 5 vial | 1990-12-20 | 0000-00-00 | No | No | Current |