LABELS · 0c1baa15-83bb-45a0-a3ab-855a4fee9129

PEMETREXED DIPOTASSIUM

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: 2025-02-05
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ( 1.1 ) initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ( 1.2 ) 1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pemetrexed for Injection is indicated for: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies ( 14.1 )] . 1.2 Mesothelioma Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

Full extracted label fields

application numbers

NDA210661

boxed warning exact

brand names

PEMETREXED DIPOTASSIUM

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc

generic names

PEMETREXED DIPOTASSIUM

0c1baa15-83bb-45a0-a3ab-855a4fee9129

indications and usage exact

1 INDICATIONS AND USAGE Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ( 1.1 ) initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ( 1.2 ) 1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pemetrexed for Injection is indicated for: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies ( 14.1 )] . 1.2 Mesothelioma Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

indications and usage tables exact

is original packager

true

manufacturer names

Avyxa Pharma, LLC

matched search terms

cancer
malignant

package ndcs

83831-111-01
83831-112-01

product ndcs

83831-111
83831-112

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1728072
1728077

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.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

NDA210661

brand names

PEMETREXED DIPOTASSIUM

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

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context span

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exact text: 1 INDICATIONS AND USAGE Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-
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current approval status

not_reconciled

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extraction review status

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generic names

PEMETREXED DIPOTASSIUM

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label id

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exact text: is a folate analog metabolic inhibitor indicated
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qualifier mentions

context exact
TIONS AND USAGE Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with
kind
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polarity
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span
end
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true
exact text
metabolic inhibitor indicated: in combinati
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context exact
the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
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exact text
metastatic
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context exact
n with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
kind
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exact text
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context exact
Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
kind
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not_inferred
span
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222
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exact text
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC
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regulatory links

schema version

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source batch sha256

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source defined aliases

abbreviation
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definition exact
Non-Small Cell Lung Cancer
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exact text
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exact text: 1 INDICATIONS AND USAGE Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
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start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%220c1baa15-83bb-45a0-a3ab-855a4fee9129%22

spl effective date

2025-02-05

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

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

NDA210661

brand names

PEMETREXED DIPOTASSIUM

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

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exact text: Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line che
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current approval status

not_reconciled

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extraction review status

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generic names

PEMETREXED DIPOTASSIUM

ind-span-e01f44d08c7517872ed3

label id

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positive predicate support span

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schema version

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source batch sha256

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source defined aliases

abbreviation
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definition exact
Non-Small Cell Lung Cancer
definition span
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exact text
Non-Small Cell Lung Cancer (NSCLC)
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exact text: ( 1.1 )
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source url

https://api.fda.gov/drug/label.json?search=id%3A%220c1baa15-83bb-45a0-a3ab-855a4fee9129%22

spl effective date

2025-02-05

spl set id

adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc

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

NDA210661

brand names

PEMETREXED DIPOTASSIUM

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

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context span

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exact text: ed for Injection is a folate analog metabolic inhibitor indicated: in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : Pemetrexed for Injection is not indicated
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current approval status

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extraction review status

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generic names

PEMETREXED DIPOTASSIUM

ind-span-a5d3e2341afe437a870e

label id

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positive predicate support span

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exact text: is a folate analog metabolic inhibitor indicated
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qualifier mentions

context exact
maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after
kind
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polarity
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exact text
metastatic
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context exact
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exact text
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context exact
ease has not progressed after four cycles of platinum-based first-line chemotherapy.
kind
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exact text
first-line chemotherapy
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context exact
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
kind
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exact text
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinu
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regulatory links

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source defined aliases

abbreviation
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definition exact
Non-Small Cell Lung Cancer
definition span
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exact text
Non-Small Cell Lung Cancer (NSCLC)
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exact text: as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
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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

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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 · unclassified context

application numbers

NDA210661

brand names

PEMETREXED DIPOTASSIUM

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

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exact text: e agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : Pemetrexed for Injection is not indicated for the
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label id

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positive predicate support span

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schema version

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source defined aliases

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Non-Small Cell Lung Cancer
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source url

https://api.fda.gov/drug/label.json?search=id%3A%220c1baa15-83bb-45a0-a3ab-855a4fee9129%22

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

unclear

Passage 5 · positive indication candidate

application numbers

NDA210661

brand names

PEMETREXED DIPOTASSIUM

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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exact text: for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ( 1.1 ) initial treatment, in combination with cis
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exact text: is a folate analog metabolic inhibitor indicated
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qualifier mentions

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exact text: as not progressed after four cycles of platinum-based first-line chemotherapy. as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies ( 14.1 )] . 1.2 Mesothelioma Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who a
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exact text: Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies ( 14.1 )] .
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exact text: after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies ( 14.1 )] . 1.2 Mesothelioma Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
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source url

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spl effective date

2025-02-05

spl set id

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spl version

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structured indication

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disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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Preserved source evidence · Not medical advice