LABELS · 517b7337-3529-4948-8d02-b8e2cf97a161

Kit for the Preparation of Technetium Tc99m Sestamibi

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2022-11-18
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1. INDICATIONS AND USAGE Technetium Tc99m Sestamibi is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: Technetium Tc99m Sestamibi is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

Full extracted label fields

application numbers

NDA019785

boxed warning exact

brand names

Kit for the Preparation of Technetium Tc99m Sestamibi

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c03a854-185a-45d7-883f-9f87e4750181

generic names

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

517b7337-3529-4948-8d02-b8e2cf97a161

indications and usage exact

1. INDICATIONS AND USAGE Technetium Tc99m Sestamibi is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: Technetium Tc99m Sestamibi is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

indications and usage tables exact

is original packager

true

manufacturer names

Lantheus Medical Imaging, Inc.

matched search terms

cancer
malignancy

package ndcs

11994-003-20

product ndcs

11994-003

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 300
total: 830

terms

https://open.fda.gov/terms/

sha256

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url

source url

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spl effective date

2022-11-18

spl effective time

20221118

spl set id

8c03a854-185a-45d7-883f-9f87e4750181

spl version

substance names

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

uniis

N6OU7HJ70P

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA019785
payload
all indexed label documents
Appl No
019785
Application Docs Date
2008-06-18 00:00:00
Application Docs ID
11716
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf
Submission No
18
Submission Type
SUPPL
Appl No
019785
Application Docs Date
2019-12-04 00:00:00
Application Docs ID
61177
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019785s022lbl.pdf
Submission No
22
Submission Type
SUPPL
all submission records
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
22
Submission Status
AP
Submission Status Date
2019-12-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
18
Submission Status
AP
Submission Status Date
2008-04-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
15
Submission Status
AP
Submission Status Date
2000-06-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
2000-02-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2000-01-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
12
Submission Status
AP
Submission Status Date
2002-01-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
11
Submission Status
AP
Submission Status Date
1998-06-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
10
Submission Status
AP
Submission Status Date
1997-08-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
9
Submission Status
AP
Submission Status Date
1997-04-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
8
Submission Status
AP
Submission Status Date
1996-09-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
7
Submission Status
AP
Submission Status Date
1996-11-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019785
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
6
Submission Status
AP
Submission Status Date
1997-05-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA019785
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019785
has approved submission record
true
latest approved submission date
2019-12-04
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
019785
Application Docs Date
2019-12-04 00:00:00
Application Docs ID
61177
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019785s022lbl.pdf
Submission No
22
Submission Type
SUPPL
official application record
Appl No
019785
Appl Public Notes
Appl Type
NDA
Sponsor Name
SHINE
openfda application present
true
products
Active Ingredient
TECHNETIUM TC-99M SESTAMIBI KIT
Appl No
019785
Drug Name
CARDIOLITE
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
1
Reference Standard
1
Strength
N/A
marketing status
Prescription
Active Ingredient
TECHNETIUM TC-99M SESTAMIBI KIT
Appl No
019785
Drug Name
MIRALUMA
Form
INJECTABLE;INJECTION
Product No
003
Reference Drug
0
Reference Standard
0
Strength
N/A
marketing status
Discontinued

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · unclassified context

application numbers

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brand names

Kit for the Preparation of Technetium Tc99m Sestamibi

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tumor histology: Source null

use intent

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Passage 2 · positive indication candidate

application numbers

NDA019785

brand names

Kit for the Preparation of Technetium Tc99m Sestamibi

classification reasons

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exact text: 1. INDICATIONS AND USAGE Technetium Tc99m Sestamibi is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: Technetium Tc99m Sestamibi is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmaco
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exact text: INDICATIONS AND USAGE Technetium Tc99m Sestamibi is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: Technetium Tc99m Sestamibi is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions.
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source url

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spl effective date

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structured fields status

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structured indication

age: Source null
approval pathway: Source null
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disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

diagnostic_candidate

Passage 3 · unclassified context

application numbers

NDA019785

brand names

Kit for the Preparation of Technetium Tc99m Sestamibi

classification reasons

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clinical review status

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exact text: e by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc99m Sestamibi is indicated fo
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use intent

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Passage 4 · unclassified context

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use intent

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Passage 5 · positive indication candidate

application numbers

NDA019785

brand names

Kit for the Preparation of Technetium Tc99m Sestamibi

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exact text: ccordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.
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age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

diagnostic_candidate

Passage 6 · limitation of use

application numbers

NDA019785

brand names

Kit for the Preparation of Technetium Tc99m Sestamibi

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1431
end exclusive: true
exact text: mibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.
label id: 517b7337-3529-4948-8d02-b8e2cf97a161
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: a12075adbf578260409cc15616a30aecb84cb30c4f46d752eff0099ac83c9192
start: 1069

current approval status

not_reconciled

duplicate text group

dup-90cfa9f6f154f03fd7cd

extraction review status

automated_candidate_pending_source_review

generic names

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

ind-span-0ddb7e098929d64ffb82

label id

517b7337-3529-4948-8d02-b8e2cf97a161

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1431
end exclusive: true
exact text: Technetium Tc99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.
label id: 517b7337-3529-4948-8d02-b8e2cf97a161
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: a12075adbf578260409cc15616a30aecb84cb30c4f46d752eff0099ac83c9192
start: 1269

source url

https://api.fda.gov/drug/label.json?search=id%3A%22517b7337-3529-4948-8d02-b8e2cf97a161%22

spl effective date

2022-11-18

spl set id

8c03a854-185a-45d7-883f-9f87e4750181

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice