Home NDC 11994-003 Kit for the Preparation of Technetium Tc99m Sestamibi
Product NDC 11994-003
11-digit product format 119940003
Labeler code 11994
Product ID 11994-003_517b7337-3529-4948-8d02-b8e2cf97a161
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 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…2022-03-09 01:35 UTC 2022-03 N019785-001 CARDIOLITE N/A INJECTABLE / INJECTION AP RLD, RS 1990-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019785-003 MIRALUMA N/A INJECTABLE / INJECTION 1997-05-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Kit for the Preparation of Technetium Tc99m Sestamibi
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11994-003-20 Kit for the Preparation of Technetium Tc99m Sestamibi 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 5 11994-003-20 Kit for the Preparation of Technetium Tc99m Sestamibi 20 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 20 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE ACTIVE INGREDIENT N6OU7HJ70P KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE ACTIVE MOIETY N6OU7HJ70P KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 CYSTEINE HYDROCHLORIDE INACTIVE INGREDIENT ZT934N0X4W KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 STANNOUS CHLORIDE INACTIVE INGREDIENT 1BQV3749L5 KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11994-003 KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20221123_8c03a854-185a-45d7-883f-9f87e4750181.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11994-003-20 11994000320 20 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIAL 20 vial 1990-12-20 0000-00-00 No No Current