LABELS · 9db15b8c-2928-4b75-a33b-548416afc8c9

Relistor

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: 2024-05-01
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1 ) • RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2 ) 1.1 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. 1.2 Opioid-Induced Constipation in Adult Patients with Advanced Illness RELISTOR injection is indicated for the treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

Full extracted label fields

application numbers

NDA208271
NDA021964

boxed warning exact

brand names

Relistor

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c488fb7c-0a5b-487c-b452-996809d1cb99

generic names

METHYLNALTREXONE BROMIDE

9db15b8c-2928-4b75-a33b-548416afc8c9

indications and usage exact

1 INDICATIONS AND USAGE • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1 ) • RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2 ) 1.1 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. 1.2 Opioid-Induced Constipation in Adult Patients with Advanced Illness RELISTOR injection is indicated for the treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

indications and usage tables exact

is original packager

true

manufacturer names

Salix Pharmaceuticals, Inc.

matched search terms

cancer

package ndcs

65649-150-90
65649-150-60
65649-150-06
65649-552-04
65649-551-07
65649-551-03
65649-551-02

product ndcs

65649-150
65649-552
65649-551

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL
SUBCUTANEOUS

rxcuis

979113
979115
1244060
1244062
1244063
1244064
1801514
1801519

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.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: 500
total: 830

terms

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

sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%229db15b8c-2928-4b75-a33b-548416afc8c9%22

spl effective date

2024-05-01

spl effective time

20240501

spl set id

c488fb7c-0a5b-487c-b452-996809d1cb99

spl version

substance names

METHYLNALTREXONE BROMIDE

uniis

RFO6IL3D3M

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
NDA021964
payload
all indexed label documents
Appl No
021964
Application Docs Date
2009-11-23 00:00:00
Application Docs ID
16646
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021964s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
021964
Application Docs Date
2010-07-30 00:00:00
Application Docs ID
16647
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021964s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
021964
Application Docs Date
2014-09-30 00:00:00
Application Docs ID
16648
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021964s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
021964
Application Docs Date
2013-08-27 00:00:00
Application Docs ID
16649
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021964s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
021964
Application Docs Date
2017-05-18 00:00:00
Application Docs ID
48437
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s017,208271s001lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
021964
Application Docs Date
2017-08-03 00:00:00
Application Docs ID
49219
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf
Submission No
18
Submission Type
SUPPL
Appl No
021964
Application Docs Date
2018-03-15 00:00:00
Application Docs ID
52966
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf
Submission No
19
Submission Type
SUPPL
all submission records
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
19
Submission Status
AP
Submission Status Date
2018-03-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
18
Submission Status
AP
Submission Status Date
2017-08-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
17
Submission Status
AP
Submission Status Date
2017-05-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
16
Submission Status
AP
Submission Status Date
2016-02-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
15
Submission Status
AP
Submission Status Date
2015-02-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
2013-12-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
12
Submission Status
AP
Submission Status Date
2015-04-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
11
Submission Status
AP
Submission Status Date
2013-08-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
10
Submission Status
AP
Submission Status Date
2014-09-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2010-07-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2010-09-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021964
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2009-11-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021964
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=021964
has approved submission record
true
latest approved submission date
2018-03-14
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
021964
Application Docs Date
2018-03-15 00:00:00
Application Docs ID
52966
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf
Submission No
19
Submission Type
SUPPL
official application record
Appl No
021964
Appl Public Notes
Appl Type
NDA
Sponsor Name
SALIX PHARMS
openfda application present
true
products
Active Ingredient
METHYLNALTREXONE BROMIDE
Appl No
021964
Drug Name
RELISTOR
Form
SOLUTION;SUBCUTANEOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
12MG/0.6ML (12MG/0.6ML)
marketing status
Prescription
Active Ingredient
METHYLNALTREXONE BROMIDE
Appl No
021964
Drug Name
RELISTOR
Form
SOLUTION;SUBCUTANEOUS
Product No
002
Reference Drug
1
Reference Standard
1
Strength
8MG/0.4ML (8MG/0.4ML)
marketing status
Prescription
Active Ingredient
METHYLNALTREXONE BROMIDE
Appl No
021964
Drug Name
RELISTOR
Form
SOLUTION;SUBCUTANEOUS
Product No
003
Reference Drug
1
Reference Standard
1
Strength
12MG/0.6ML (12MG/0.6ML)
marketing status
Prescription
application number
NDA208271
payload
all indexed label documents
Appl No
208271
Application Docs Date
2016-07-21 00:00:00
Application Docs ID
40630
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208271s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
208271
Application Docs Date
2017-05-18 00:00:00
Application Docs ID
48436
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s017,208271s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
208271
Application Docs Date
2017-08-03 00:00:00
Application Docs ID
49220
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
208271
Application Docs Date
2018-03-15 00:00:00
Application Docs ID
52967
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf
Submission No
3
Submission Type
SUPPL
all submission records
Appl No
208271
Review Priority
STANDARD
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2016-07-19 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
208271
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2017-05-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208271
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2017-08-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
208271
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2018-03-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA208271
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=208271
has approved submission record
true
latest approved submission date
2018-03-14
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
208271
Application Docs Date
2018-03-15 00:00:00
Application Docs ID
52967
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf
Submission No
3
Submission Type
SUPPL
official application record
Appl No
208271
Appl Public Notes
Appl Type
NDA
Sponsor Name
SALIX
openfda application present
true
products
Active Ingredient
METHYLNALTREXONE BROMIDE
Appl No
208271
Drug Name
RELISTOR
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
150MG
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

NDA208271
NDA021964

brand names

Relistor

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 223
end exclusive: true
exact text: 1 INDICATIONS AND USAGE • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including pati
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extraction review status

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generic names

METHYLNALTREXONE BROMIDE

ind-span-66b4ab62f32420dd350a

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9db15b8c-2928-4b75-a33b-548416afc8c9

positive predicate support span

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qualifier mentions

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source batch sha256

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source defined aliases

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source url

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spl effective date

2024-05-01

spl set id

c488fb7c-0a5b-487c-b452-996809d1cb99

spl version

structured fields status

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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

unclear

Passage 2 · unclassified context

application numbers

NDA208271
NDA021964

brand names

Relistor

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 259
end exclusive: true
exact text: 1 INDICATIONS AND USAGE • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to pr
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current approval status

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dup-c2c2a5e1cb61e304abe7

extraction review status

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generic names

METHYLNALTREXONE BROMIDE

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label id

9db15b8c-2928-4b75-a33b-548416afc8c9

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exact text: • RELISTOR is an opioid antagonist.
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source url

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spl effective date

2024-05-01

spl set id

c488fb7c-0a5b-487c-b452-996809d1cb99

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

Passage 3 · positive indication candidate

application numbers

NDA208271
NDA021964

brand names

Relistor

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 555
end exclusive: true
exact text: 1 INDICATIONS AND USAGE • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1 ) • RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2 ) 1.
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current approval status

not_reconciled

duplicate text group

dup-20e74169afb2d3f8ac3e

extraction review status

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generic names

METHYLNALTREXONE BROMIDE

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label id

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positive predicate support span

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exact text: are indicated
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qualifier mentions

context exact
d for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chron
kind
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regulatory links

schema version

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source batch sha256

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source defined aliases

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exact text: RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
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offset unit: unicode_code_points
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source url

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spl effective date

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spl set id

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spl version

structured fields status

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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

supportive_care_candidate

Passage 4 · unclassified context

application numbers

NDA208271
NDA021964

brand names

Relistor

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 563
end exclusive: true
exact text: pation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1 ) • RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2 ) 1.1 Opioid
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