LABELS · dd40946b-b83f-48fe-8946-16e7c35e183b

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

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: 2026-08-28
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. ( 1 ) • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. ( 1 )

Full extracted label fields

application numbers

NDA202207

boxed warning exact

brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72f31b09-4d7b-475c-b37a-9daf2ad80240

generic names

TILMANOCEPT

dd40946b-b83f-48fe-8946-16e7c35e183b

indications and usage exact

1 INDICATIONS AND USAGE Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. ( 1 ) • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Cardinal Health 414, LLC

matched search terms

cancer
carcinoma
melanoma
tumor
tumors

package ndcs

65857-425-05
65857-400-01
65857-450-05
65857-401-45

product ndcs

65857-425
65857-450

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.json

Source passages and status connections

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

Passage 1 · positive indication candidate

application numbers

NDA202207

brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

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exact text: 1 INDICATIONS AND USAGE Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedu
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qualifier mentions

context exact
SAGE Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
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polarity
not_inferred
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exact text
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exact text: 1 INDICATIONS AND USAGE Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
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source url

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spl effective date

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spl version

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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 2 · positive indication candidate

application numbers

NDA202207

brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

classification reasons

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clinical review status

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context span

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exact text: 1 INDICATIONS AND USAGE Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is a ra
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qualifier mentions

context exact
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context exact
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source url

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spl effective date

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structured indication

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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

tumor_directed_candidate

Passage 3 · positive indication candidate

application numbers

NDA202207

brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

classification reasons

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exact text: ter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor sit
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source url

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spl effective date

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spl version

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structured indication

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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

tumor_directed_candidate

Passage 4 · positive indication candidate

application numbers

NDA202207

brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

classification reasons

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diagnostic_use_words

clinical review status

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exact text: rative management. • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedu
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qualifier mentions

context exact
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tumor histology: Source null

use intent

diagnostic_candidate

Passage 5 · positive indication candidate

application numbers

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brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

classification reasons

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exact text: with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. ( 1 ) • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. ( 1 )
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prior therapy: Source null
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tumor histology: Source null

use intent

tumor_directed_candidate

Passage 6 · unclassified context

application numbers

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brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

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exact text: ter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. ( 1 ) • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. ( 1 )
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source url

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tumor histology: Source null

use intent

unclear

Passage 7 · positive indication candidate

application numbers

NDA202207

brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

classification reasons

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dup-7d38bacadf27bfd0d196

extraction review status

automated_candidate_pending_source_review

generic names

TILMANOCEPT

ind-span-932b2125c863f81e89bd

label id

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positive predicate support span

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exact text: is a radioactive diagnostic agent indicated
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source text sha256: de34e22f04fc68b577f85a29bb6628b4453fab84a90ca18d38458b68d471c351
start: 561

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 1081
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exact text: • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22dd40946b-b83f-48fe-8946-16e7c35e183b%22

spl effective date

2026-08-28

spl set id

72f31b09-4d7b-475c-b37a-9daf2ad80240

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

tumor_directed_candidate

Passage 8 · unclassified context

application numbers

NDA202207

brand names

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1087
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exact text: management. ( 1 ) • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. ( 1 )
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current approval status

not_reconciled

duplicate text group

dup-9397c986563b37e738b0

extraction review status

automated_candidate_pending_source_review

generic names

TILMANOCEPT

ind-span-33f36f3d937a2ede7cba

label id

dd40946b-b83f-48fe-8946-16e7c35e183b

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: 1087
end exclusive: true
exact text: ( 1 )
label id: dd40946b-b83f-48fe-8946-16e7c35e183b
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source text sha256: de34e22f04fc68b577f85a29bb6628b4453fab84a90ca18d38458b68d471c351
start: 1082

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dd40946b-b83f-48fe-8946-16e7c35e183b%22

spl effective date

2026-08-28

spl set id

72f31b09-4d7b-475c-b37a-9daf2ad80240

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

unclear

Preserved source evidence · Not medical advice