LABELS · 3d7648ab-7b11-495d-925c-3a991065237e

OCTREOSCAN

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: 2022-02-21
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.

Full extracted label fields

application numbers

NDA020314

boxed warning exact

brand names

OCTREOSCAN

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=93d8f3b2-1216-41dc-a63d-0e812b33891d

generic names

INDIUM IN -111 PENTETREOTIDE

3d7648ab-7b11-495d-925c-3a991065237e

indications and usage exact

INDICATIONS AND USAGE Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.

indications and usage tables exact

is original packager

true

manufacturer names

Curium US LLC

matched search terms

tumors

package ndcs

69945-050-40

product ndcs

69945-050

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-00200.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: 200
total: 830

terms

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

sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%223d7648ab-7b11-495d-925c-3a991065237e%22

spl effective date

2022-02-21

spl effective time

20220221

spl set id

93d8f3b2-1216-41dc-a63d-0e812b33891d

spl version

substance names

uniis

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
NDA020314
payload
all indexed label documents
Appl No
020314
Application Docs Date
2021-12-27 00:00:00
Application Docs ID
69778
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020314S014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
020314
Application Docs Date
2022-02-11 00:00:00
Application Docs ID
70147
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020314Orig1s012lbl.pdf
Submission No
12
Submission Type
SUPPL
all submission records
Appl No
020314
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
1994-06-02 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
020314
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
1994-12-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020314
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
2
Submission Status
AP
Submission Status Date
1998-04-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020314
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
12
Submission Status
AP
Submission Status Date
2022-02-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020314
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2021-12-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA020314
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=020314
has approved submission record
true
latest approved submission date
2022-02-09
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
020314
Application Docs Date
2022-02-11 00:00:00
Application Docs ID
70147
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020314Orig1s012lbl.pdf
Submission No
12
Submission Type
SUPPL
official application record
Appl No
020314
Appl Public Notes
Appl Type
NDA
Sponsor Name
CURIUM
openfda application present
true
products
Active Ingredient
INDIUM IN-111 PENTETREOTIDE KIT
Appl No
020314
Drug Name
OCTREOSCAN
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
1
Reference Standard
1
Strength
3mCi/ML
marketing status
Prescription

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

NDA020314

brand names

OCTREOSCAN

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 181
end exclusive: true
exact text: INDICATIONS AND USAGE Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
label id: 3d7648ab-7b11-495d-925c-3a991065237e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: db4337527e5d9a411be8ca49d676fe0f7b7a5eeaf2eb4a8e1186317d63c65368
start: 0

current approval status

not_reconciled

duplicate text group

dup-6476120c657b447fe8e5

extraction review status

automated_candidate_pending_source_review

generic names

INDIUM IN -111 PENTETREOTIDE

ind-span-848071d5f03c51983202

label id

3d7648ab-7b11-495d-925c-3a991065237e

positive predicate support span

Source null

qualifier mentions

context exact
an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
kind
biomarker
polarity
not_inferred
span
end
160
end exclusive
true
exact text
metastatic neuroendocrine tumors bearing so
label id
3d7648ab-7b11-495d-925c-3a991065237e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
db4337527e5d9a411be8ca49d676fe0f7b7a5eeaf2eb4a8e1186317d63c65368
start
117
context exact
an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
kind
stage_or_setting
polarity
not_inferred
span
end
162
end exclusive
true
exact text
metastatic neuroendocrine tumors bearing soma
label id
3d7648ab-7b11-495d-925c-3a991065237e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
db4337527e5d9a411be8ca49d676fe0f7b7a5eeaf2eb4a8e1186317d63c65368
start
117

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 181
end exclusive: true
exact text: INDICATIONS AND USAGE Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
label id: 3d7648ab-7b11-495d-925c-3a991065237e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: db4337527e5d9a411be8ca49d676fe0f7b7a5eeaf2eb4a8e1186317d63c65368
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%223d7648ab-7b11-495d-925c-3a991065237e%22

spl effective date

2022-02-21

spl set id

93d8f3b2-1216-41dc-a63d-0e812b33891d

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