LABELS · d515f49a-8eb4-42f3-a7ee-1634a4804ca5

Cardiolite

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: 2022-12-06
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1. INDICATIONS AND USAGE CARDIOLITE® 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: CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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. CARDIOLITE ® 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: MIRALUMA ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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. MIRALUMA ® 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

Cardiolite

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49662def-2fb9-47b2-8467-ca56f6006167

generic names

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

d515f49a-8eb4-42f3-a7ee-1634a4804ca5

indications and usage exact

1. INDICATIONS AND USAGE CARDIOLITE® 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: CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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. CARDIOLITE ® 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: MIRALUMA ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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. MIRALUMA ® 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

11994-001-55
11994-001-20

product ndcs

11994-001

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-00700.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

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skip: 700
total: 830

terms

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

sha256

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url

source url

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spl effective date

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spl effective time

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spl set id

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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

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use intent

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Passage 2 · positive indication candidate

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exact text: 1. INDICATIONS AND USAGE CARDIOLITE® 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: CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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. CARDIOLITE ® 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 a
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TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

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exact text: INDICATIONS AND USAGE CARDIOLITE® 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: CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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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spl effective date

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structured fields status

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structured indication

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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

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Passage 3 · unclassified context

application numbers

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brand names

Cardiolite

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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. CARDIOLITE ® 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: MIRALUMA ® , Kit for the Preparation of Te
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Passage 4 · unclassified context

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exact text: uation 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: MIRALUMA ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the e
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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: MIRALUMA ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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. MIRALUMA ® 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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exact text: Breast Imaging: MIRALUMA ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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.
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start: 1059

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d515f49a-8eb4-42f3-a7ee-1634a4804ca5%22

spl effective date

2022-12-06

spl set id

49662def-2fb9-47b2-8467-ca56f6006167

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

diagnostic_candidate

Passage 6 · limitation of use

application numbers

NDA019785

brand names

Cardiolite

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1498
end exclusive: true
exact text: ion, 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. MIRALUMA ® 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: d515f49a-8eb4-42f3-a7ee-1634a4804ca5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: cb08ce95edcd73952d48d629e06c6b4c15ccb1008815eb389c24e8cbcf92eaa6
start: 1152

current approval status

not_reconciled

duplicate text group

dup-d641fb341ee6ec0f9d90

extraction review status

automated_candidate_pending_source_review

generic names

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

ind-span-0fc4078a216c487d3d2d

label id

d515f49a-8eb4-42f3-a7ee-1634a4804ca5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 1498
end exclusive: true
exact text: MIRALUMA ® 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: d515f49a-8eb4-42f3-a7ee-1634a4804ca5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: cb08ce95edcd73952d48d629e06c6b4c15ccb1008815eb389c24e8cbcf92eaa6
start: 1352

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d515f49a-8eb4-42f3-a7ee-1634a4804ca5%22

spl effective date

2022-12-06

spl set id

49662def-2fb9-47b2-8467-ca56f6006167

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