LABELS · 42c2c9c2-6929-4952-b559-a57a1d75424e

Sensipar

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: 2025-12-07
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Sensipar is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies ( 14.1 )]. Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions ( 5.1 )] . 1.2 Parathyroid Carcinoma Sensipar is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies ( 14.2 )] . 1.3 Primary Hyperparathyroidism Sensipar is indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see Clinical Studies ( 14.3 )] .

Full extracted label fields

application numbers

NDA021688

boxed warning exact

brand names

Sensipar

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45028573-13c4-4c8b-ae62-6c75bba97c81

generic names

CINACALCET HYDROCHLORIDE

42c2c9c2-6929-4952-b559-a57a1d75424e

indications and usage exact

1 INDICATIONS AND USAGE Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Sensipar is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies ( 14.1 )]. Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions ( 5.1 )] . 1.2 Parathyroid Carcinoma Sensipar is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies ( 14.2 )] . 1.3 Primary Hyperparathyroidism Sensipar is indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see Clinical Studies ( 14.3 )] .

indications and usage tables exact

is original packager

true

manufacturer names

Amgen Inc

matched search terms

carcinoma

package ndcs

55513-073-30
55513-074-30
55513-075-30

product ndcs

55513-073
55513-074
55513-075

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

432400
432401
432402
656137
706958
706960

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%2242c2c9c2-6929-4952-b559-a57a1d75424e%22

spl effective date

2025-12-07

spl effective time

20251207

spl set id

45028573-13c4-4c8b-ae62-6c75bba97c81

spl version

136

substance names

CINACALCET HYDROCHLORIDE

uniis

1K860WSG25

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
NDA021688
payload
all indexed label documents
Appl No
021688
Application Docs Date
2004-04-05 00:00:00
Application Docs ID
15983
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021688
Application Docs Date
2008-03-05 00:00:00
Application Docs ID
15984
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2014-11-25 00:00:00
Application Docs ID
15985
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf
Submission No
20
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2007-10-10 00:00:00
Application Docs ID
37452
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021688s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2009-01-06 00:00:00
Application Docs ID
37453
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2009-11-16 00:00:00
Application Docs ID
37454
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021688s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2011-03-04 00:00:00
Application Docs ID
37455
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s015lbl.pdf
Submission No
15
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2011-08-12 00:00:00
Application Docs ID
37456
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2014-11-25 00:00:00
Application Docs ID
37457
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf
Submission No
21
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2014-11-25 00:00:00
Application Docs ID
37458
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf
Submission No
22
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2017-05-17 00:00:00
Application Docs ID
48389
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s024lbl.pdf
Submission No
24
Submission Type
SUPPL
Appl No
021688
Application Docs Date
2017-05-25 00:00:00
Application Docs ID
48540
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s023lbl.pdf
Submission No
23
Submission Type
SUPPL
all submission records
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
27
Submission Status
AP
Submission Status Date
2019-12-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
26
Submission Status
AP
Submission Status Date
2019-03-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
25
Submission Status
AP
Submission Status Date
2019-03-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
901 REQUIRED
Submission Class Code ID
3
Submission No
24
Submission Status
AP
Submission Status Date
2017-05-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
23
Submission Status
AP
Submission Status Date
2017-05-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
22
Submission Status
AP
Submission Status Date
2014-11-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
21
Submission Status
AP
Submission Status Date
2014-11-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
20
Submission Status
AP
Submission Status Date
2014-11-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
17
Submission Status
AP
Submission Status Date
2011-08-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
15
Submission Status
AP
Submission Status Date
2011-02-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2009-11-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021688
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
11
Submission Status
AP
Submission Status Date
2008-12-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021688
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=021688
has approved submission record
true
latest approved submission date
2019-12-05
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
021688
Application Docs Date
2019-12-10 00:00:00
Application Docs ID
61219
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s027lbl.pdf
Submission No
27
Submission Type
SUPPL
official application record
Appl No
021688
Appl Public Notes
Appl Type
NDA
Sponsor Name
AMGEN
openfda application present
true
products
Active Ingredient
CINACALCET HYDROCHLORIDE
Appl No
021688
Drug Name
SENSIPAR
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 30MG BASE
marketing status
Discontinued
Active Ingredient
CINACALCET HYDROCHLORIDE
Appl No
021688
Drug Name
SENSIPAR
Form
TABLET;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
EQ 60MG BASE
marketing status
Discontinued
Active Ingredient
CINACALCET HYDROCHLORIDE
Appl No
021688
Drug Name
SENSIPAR
Form
TABLET;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
EQ 90MG BASE
marketing status
Discontinued

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

NDA021688

brand names

Sensipar

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

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exact text: 1 INDICATIONS AND USAGE Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in ad
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start: 0

current approval status

not_reconciled

duplicate text group

dup-6103db46f281574bb841

extraction review status

automated_candidate_pending_source_review

generic names

CINACALCET HYDROCHLORIDE

ind-span-f1d1efd1976837dc657c

label id

42c2c9c2-6929-4952-b559-a57a1d75424e

positive predicate support span

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exact text: is a positive modulator of the calcium sensing receptor indicated
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qualifier mentions

context exact
eptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
kind
age
polarity
not_inferred
span
end
157
end exclusive
true
exact text
adult patients
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source field
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source text sha256
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start
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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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end exclusive: true
exact text: 1 INDICATIONS AND USAGE Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 78cb7e52223f664b76544753741fa4c167b52a89727828c4ee2cb15a1c7c7dbc
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2242c2c9c2-6929-4952-b559-a57a1d75424e%22

spl effective date

2025-12-07

spl set id

45028573-13c4-4c8b-ae62-6c75bba97c81

spl version

136

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 · limitation of use

application numbers

NDA021688

brand names

Sensipar

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 576
end exclusive: true
exact text: ICATIONS AND USAGE Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. ( 1.3 ) 1
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current approval status

not_reconciled

duplicate text group

dup-ab38c58b70babd9c9999

extraction review status

automated_candidate_pending_source_review

generic names

CINACALCET HYDROCHLORIDE

ind-span-23edd5f7cafa34a0e1af

label id

42c2c9c2-6929-4952-b559-a57a1d75424e

positive predicate support span

Source null

qualifier mentions

context exact
patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC).
kind
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polarity
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exact text
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source text sha256
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start
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regulatory links

schema version

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source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 376
end exclusive: true
exact text: ( 1.1 ) Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC).
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source array index: 0
source field: indications_and_usage_exact
source text sha256: 78cb7e52223f664b76544753741fa4c167b52a89727828c4ee2cb15a1c7c7dbc
start: 205

source url

https://api.fda.gov/drug/label.json?search=id%3A%2242c2c9c2-6929-4952-b559-a57a1d75424e%22

spl effective date

2025-12-07

spl set id

45028573-13c4-4c8b-ae62-6c75bba97c81

spl version

136

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

not_applicable

Passage 3 · unclassified context

application numbers

NDA021688

brand names

Sensipar

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 766
end exclusive: true
exact text: disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Sensipar is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical
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current approval status

not_reconciled

duplicate text group

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extraction review status

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generic names

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ind-span-77c014000de0738b7da9

label id

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positive predicate support span

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qualifier mentions

context exact
( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indica
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exact text
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source text sha256
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start
402

regulatory links

schema version

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source batch sha256

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source defined aliases

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exact text: ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.
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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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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 4 · unclassified context

application numbers

NDA021688

brand names

Sensipar

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

unclassified_context

context span

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Preserved source evidence · Not medical advice