LABELS · 56918f19-7843-4f63-e063-6294a90a981c

Lubiprostone

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: 2026-07-14
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) 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 ) Limitations of Use: Effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. ( 1.2 , 7.1 ) irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old. ( 1.3 ) 1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is 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. Limitations of Use: Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies (14.2) ] 1.3 Irritable Bowel Syndrome with Constipation Lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.

Full extracted label fields

application numbers

NDA021908

boxed warning exact

brand names

Lubiprostone

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f06d76d2-028a-629f-e053-2995a90a80f5

generic names

LUBIPROSTONE

56918f19-7843-4f63-e063-6294a90a981c

indications and usage exact

1 INDICATIONS AND USAGE Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) 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 ) Limitations of Use: Effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. ( 1.2 , 7.1 ) irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old. ( 1.3 ) 1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is 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. Limitations of Use: Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies (14.2) ] 1.3 Irritable Bowel Syndrome with Constipation Lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.

indications and usage tables exact

is original packager

true

manufacturer names

Sun Pharmaceutical Industries, Inc.

matched search terms

cancer

package ndcs

63304-351-60
63304-352-60

product ndcs

63304-351
63304-352

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

616578
794639

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

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2256918f19-7843-4f63-e063-6294a90a981c%22

spl effective date

2026-07-14

spl effective time

20260714

spl set id

f06d76d2-028a-629f-e053-2995a90a80f5

spl version

substance names

LUBIPROSTONE

uniis

7662KG2R6K

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
NDA021908
payload
all indexed label documents
Appl No
021908
Application Docs Date
2008-05-02 00:00:00
Application Docs ID
16555
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021908s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2011-03-04 00:00:00
Application Docs ID
16556
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021908s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2012-11-26 00:00:00
Application Docs ID
16557
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2013-04-23 00:00:00
Application Docs ID
16558
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021908s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2006-02-02 00:00:00
Application Docs ID
37863
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021908
Application Docs Date
2007-05-29 00:00:00
Application Docs ID
37864
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021908s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2016-11-01 00:00:00
Application Docs ID
45750
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021908s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2017-08-02 00:00:00
Application Docs ID
49204
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021908s015lbl.pdf
Submission No
15
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2018-04-27 00:00:00
Application Docs ID
53862
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021908s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
021908
Application Docs Date
2020-12-04 00:00:00
Application Docs ID
65500
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021908s018lbl.pdf
Submission No
18
Submission Type
SUPPL
all submission records
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
18
Submission Status
AP
Submission Status Date
2020-11-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
16
Submission Status
AP
Submission Status Date
2018-04-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
2017-08-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2016-10-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
12
Submission Status
AP
Submission Status Date
2013-08-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
11
Submission Status
AP
Submission Status Date
2013-04-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2012-11-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2011-02-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
UNKNOWN
Submission Class Code ID
2
Submission No
5
Submission Status
AP
Submission Status Date
2008-04-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2007-05-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021908
Review Priority
STANDARD
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2006-01-31 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA021908
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=021908
has approved submission record
true
latest approved submission date
2020-11-30
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
021908
Application Docs Date
2020-12-04 00:00:00
Application Docs ID
65500
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021908s018lbl.pdf
Submission No
18
Submission Type
SUPPL
official application record
Appl No
021908
Appl Public Notes
Appl Type
NDA
Sponsor Name
SUCAMPO PHARMA LLC
openfda application present
true
products
Active Ingredient
LUBIPROSTONE
Appl No
021908
Drug Name
AMITIZA
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
24MCG
marketing status
Prescription
Active Ingredient
LUBIPROSTONE
Appl No
021908
Drug Name
AMITIZA
Form
CAPSULE;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
8MCG
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 · positive indication candidate

application numbers

NDA021908

brand names

Lubiprostone

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

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exact text: 1 INDICATIONS AND USAGE Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) 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
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current approval status

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extraction review status

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generic names

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qualifier mentions

context exact
the treatment of: chronic idiopathic constipation (CIC) in adults.
kind
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end exclusive
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exact text
adults
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regulatory links

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source defined aliases

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source url

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spl effective date

2026-07-14

spl set id

f06d76d2-028a-629f-e053-2995a90a80f5

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

non_oncology_or_unclear_candidate

Passage 2 · positive indication candidate

application numbers

NDA021908

brand names

Lubiprostone

classification reasons

inherited_predicate_from_same_label_section_requires_review
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 587
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) 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 ) Limitations of Use: Effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. ( 1.2 , 7.1 ) irritable bowel
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extraction review status

automated_candidate_pending_source_review

generic names

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positive predicate support span

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qualifier mentions

context exact
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regulatory links

schema version

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source defined aliases

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exact text: ( 1.1 ) 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.
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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

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limitations: Source null
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prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Passage 3 · limitation of use

application numbers

NDA021908

brand names

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classification reasons

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clinical review status

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positive predicate support span

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qualifier mentions

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source url

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spl effective date

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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

not_applicable

Passage 4 · unclassified context

application numbers

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brand names

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clinical review status

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positive predicate support span

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qualifier mentions

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