LABELS · 428f7828-6d1c-438b-a17d-b4af0700c740

EMEND

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: 2024-07-05
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE EMEND ® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® is a substance P/neurokinin 1 (NK 1 ) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1 ) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1 ) EMEND capsules is indicated in combination with other antiemetic agents, in patients 12 years of age and older for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1 ) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1 ) Limitations of Use ( 1 ) EMEND has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended. Limitations of Use EMEND has not been studied for the treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

Full extracted label fields

application numbers

NDA021549
NDA207865

boxed warning exact

brand names

EMEND

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=696f9e80-9cae-403b-de9e-078343ce4713

generic names

APREPITANT

428f7828-6d1c-438b-a17d-b4af0700c740

indications and usage exact

1 INDICATIONS AND USAGE EMEND ® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® is a substance P/neurokinin 1 (NK 1 ) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1 ) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1 ) EMEND capsules is indicated in combination with other antiemetic agents, in patients 12 years of age and older for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1 ) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1 ) Limitations of Use ( 1 ) EMEND has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended. Limitations of Use EMEND has not been studied for the treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

indications and usage tables exact

is original packager

true

manufacturer names

Merck Sharp & Dohme LLC

matched search terms

cancer

package ndcs

0006-0461-02
0006-0461-01
0006-0461-06
0006-0461-12
0006-0462-01
0006-0462-06
0006-3862-03
0006-3862-13
0006-0464-01
0006-0464-10
0006-0464-05
0006-3066-01

product ndcs

0006-0461
0006-0462
0006-3862
0006-0464
0006-3066

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

403810
403811
404465
404466
644088
644278
754508
754509
1729308
1729311

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%22428f7828-6d1c-438b-a17d-b4af0700c740%22

spl effective date

2024-07-05

spl effective time

20240705

spl set id

696f9e80-9cae-403b-de9e-078343ce4713

spl version

substance names

APREPITANT

uniis

1NF15YR6UY

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
NDA021549
payload
all indexed label documents
Appl No
021549
Application Docs Date
2005-06-14 00:00:00
Application Docs ID
15763
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2006-07-03 00:00:00
Application Docs ID
15764
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2007-11-19 00:00:00
Application Docs ID
15765
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021549s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2009-02-04 00:00:00
Application Docs ID
15766
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2010-03-26 00:00:00
Application Docs ID
15767
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021549s017lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2013-04-01 00:00:00
Application Docs ID
15768
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s023lbl.pdf
Submission No
23
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2014-08-13 00:00:00
Application Docs ID
15769
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021549s024lbl.pdf
Submission No
24
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2015-09-03 00:00:00
Application Docs ID
15770
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021549s025lbl.pdf
Submission No
25
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2003-03-28 00:00:00
Application Docs ID
37204
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21549_Emend_lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021549
Application Docs Date
2004-12-30 00:00:00
Application Docs ID
37205
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2004-12-29 00:00:00
Application Docs ID
37206
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
021549
Application Docs Date
2005-11-01 00:00:00
Application Docs ID
37207
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s008lbl.pdf
Submission No
8
Submission Type
SUPPL
all submission records
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
31
Submission Status
AP
Submission Status Date
2019-09-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
30
Submission Status
AP
Submission Status Date
2019-11-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
27
Submission Status
AP
Submission Status Date
2017-05-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
26
Submission Status
AP
Submission Status Date
2015-01-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
25
Submission Status
AP
Submission Status Date
2015-08-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
24
Submission Status
AP
Submission Status Date
2014-08-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
23
Submission Status
AP
Submission Status Date
2013-03-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
21
Submission Status
AP
Submission Status Date
2012-07-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
19
Submission Status
AP
Submission Status Date
2013-03-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
17
Submission Status
AP
Submission Status Date
2010-03-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
16
Submission Status
AP
Submission Status Date
2009-02-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021549
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
2008-11-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021549
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=021549
has approved submission record
true
latest approved submission date
2019-11-14
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
021549
Application Docs Date
2019-11-15 00:00:00
Application Docs ID
60853
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf
Submission No
30
Submission Type
SUPPL
official application record
Appl No
021549
Appl Public Notes
Appl Type
NDA
Sponsor Name
MSD
openfda application present
true
products
Active Ingredient
APREPITANT
Appl No
021549
Drug Name
EMEND
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
80MG
marketing status
Prescription
Active Ingredient
APREPITANT
Appl No
021549
Drug Name
EMEND
Form
CAPSULE;ORAL
Product No
002
Reference Drug
1
Reference Standard
1
Strength
125MG
marketing status
Prescription
Active Ingredient
APREPITANT
Appl No
021549
Drug Name
EMEND
Form
CAPSULE;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
marketing status
Discontinued
application number
NDA207865
payload
all indexed label documents
Appl No
207865
Application Docs Date
2015-12-18 00:00:00
Application Docs ID
40593
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207865lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
207865
Application Docs Date
2017-06-01 00:00:00
Application Docs ID
48617
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
207865
Application Docs Date
2019-09-26 00:00:00
Application Docs ID
60126
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s031,207865s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
207865
Application Docs Date
2019-11-15 00:00:00
Application Docs ID
60854
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf
Submission No
3
Submission Type
SUPPL
all submission records
Appl No
207865
Review Priority
PRIORITY
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2015-12-17 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
207865
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2017-05-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
207865
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2019-11-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
207865
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2019-09-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA207865
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=207865
has approved submission record
true
latest approved submission date
2019-11-14
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
207865
Application Docs Date
2019-11-15 00:00:00
Application Docs ID
60854
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf
Submission No
3
Submission Type
SUPPL
official application record
Appl No
207865
Appl Public Notes
Appl Type
NDA
Sponsor Name
MSD MERCK CO
openfda application present
true
products
Active Ingredient
APREPITANT
Appl No
207865
Drug Name
EMEND
Form
FOR SUSPENSION;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
125MG/KIT
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

NDA021549
NDA207865

brand names

EMEND

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

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exact text: 1 INDICATIONS AND USAGE EMEND ® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial
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current approval status

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generic names

APREPITANT

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qualifier mentions

context exact
1 INDICATIONS AND USAGE EMEND ® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherap
kind
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exact text
in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initia
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regulatory links

schema version

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source batch sha256

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source defined aliases

source span

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exact text: 1 INDICATIONS AND USAGE EMEND ® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
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source url

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spl effective date

2024-07-05

spl set id

696f9e80-9cae-403b-de9e-078343ce4713

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

supportive_care_candidate

Passage 2 · positive indication candidate

application numbers

NDA021549
NDA207865

brand names

EMEND

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1056
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exact text: ourses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® is a substance P/neurokinin 1 (NK 1 ) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for preven
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duplicate text group

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extraction review status

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generic names

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positive predicate support span

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qualifier mentions

context exact
tion with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of: acute and delayed nausea a
kind
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