LABELS · dd4a56ce-80e3-4794-94a8-cb2b14695b89

Dantrium

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: 2026-03-10
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE: Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever). Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.

Full extracted label fields

application numbers

NDA018264

boxed warning exact

brand names

Dantrium

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4df35098-8702-46be-ac67-30cfdf1aa570

generic names

DANTROLENE SODIUM

dd4a56ce-80e3-4794-94a8-cb2b14695b89

indications and usage exact

INDICATIONS AND USAGE: Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever). Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.

indications and usage tables exact

is original packager

true

manufacturer names

Par Health USA, LLC

matched search terms

malignant

package ndcs

42023-123-06

product ndcs

42023-123

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

856696
856698

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.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: 700
total: 830

terms

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

sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dd4a56ce-80e3-4794-94a8-cb2b14695b89%22

spl effective date

2026-03-10

spl effective time

20260310

spl set id

4df35098-8702-46be-ac67-30cfdf1aa570

spl version

substance names

DANTROLENE SODIUM

uniis

287M0347EV

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
NDA018264
payload
all indexed label documents
Appl No
018264
Application Docs Date
2008-11-07 00:00:00
Application Docs ID
11188
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf
Submission No
25
Submission Type
SUPPL
Appl No
018264
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78047
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018264s042lbl.pdf
Submission No
42
Submission Type
SUPPL
all submission records
Appl No
018264
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
42
Submission Status
AP
Submission Status Date
2024-04-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
25
Submission Status
AP
Submission Status Date
2008-10-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
22
Submission Status
AP
Submission Status Date
2001-10-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
21
Submission Status
AP
Submission Status Date
2001-07-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
19
Submission Status
AP
Submission Status Date
2000-08-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
17
Submission Status
AP
Submission Status Date
1989-02-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
16
Submission Status
AP
Submission Status Date
1988-06-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
1989-06-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
1987-12-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
13
Submission Status
AP
Submission Status Date
1987-06-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
12
Submission Status
AP
Submission Status Date
1985-08-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018264
Review Priority
Submission Class Code ID
2
Submission No
11
Submission Status
AP
Submission Status Date
1987-05-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA018264
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=018264
has approved submission record
true
latest approved submission date
2024-04-02
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
018264
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78047
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018264s042lbl.pdf
Submission No
42
Submission Type
SUPPL
official application record
Appl No
018264
Appl Public Notes
Appl Type
NDA
Sponsor Name
PH HEALTH
openfda application present
true
products
Active Ingredient
DANTROLENE SODIUM
Appl No
018264
Drug Name
DANTRIUM
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
1
Reference Standard
1
Strength
20MG/VIAL
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

NDA018264

brand names

Dantrium

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 445
end exclusive: true
exact text: INDICATIONS AND USAGE: Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturatio
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 0

current approval status

not_reconciled

duplicate text group

dup-162c2ee7fa9991e9f397

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-7db24d683aeec2421694

label id

dd4a56ce-80e3-4794-94a8-cb2b14695b89

positive predicate support span

end: 56
end exclusive: true
exact text: is indicated
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 44

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 245
end exclusive: true
exact text: INDICATIONS AND USAGE: Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages.
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dd4a56ce-80e3-4794-94a8-cb2b14695b89%22

spl effective date

2026-03-10

spl set id

4df35098-8702-46be-ac67-30cfdf1aa570

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 · unclassified context

application numbers

NDA018264

brand names

Dantrium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 838
end exclusive: true
exact text: indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever). Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 46

current approval status

not_reconciled

duplicate text group

dup-ed418fded360d1748437

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-be8c85863a99670ef496

label id

dd4a56ce-80e3-4794-94a8-cb2b14695b89

positive predicate support span

Source null

qualifier mentions

context exact
ardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthe
kind
biomarker
polarity
not_inferred
span
end
479
end exclusive
true
exact text
metabolic acidosis
label id
dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start
461

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 638
end exclusive: true
exact text: Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 246

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dd4a56ce-80e3-4794-94a8-cb2b14695b89%22

spl effective date

2026-03-10

spl set id

4df35098-8702-46be-ac67-30cfdf1aa570

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

NDA018264

brand names

Dantrium

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 887
end exclusive: true
exact text: uration, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever). Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 439

current approval status

not_reconciled

duplicate text group

dup-c72405ec5a7dae436030

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-f9baf329c62bf81d78c3

label id

dd4a56ce-80e3-4794-94a8-cb2b14695b89

positive predicate support span

end: 677
end exclusive: true
exact text: is also indicated
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 660

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 887
end exclusive: true
exact text: Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.
label id: dd4a56ce-80e3-4794-94a8-cb2b14695b89
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7a94d571b80e633ddc29be9aa29dcb005ec0903949fb79e1e4e347c64b3facc5
start: 639

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dd4a56ce-80e3-4794-94a8-cb2b14695b89%22

spl effective date

2026-03-10

spl set id

4df35098-8702-46be-ac67-30cfdf1aa570

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

Preserved source evidence · Not medical advice