Sensipar

Product NDC: 53808-0578
11-digit product format: 538080578
Labeler code: 53808
Product ID: 53808-0578_29dcedcd-efba-436a-8542-99faff58875f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cinacalcet hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: NDA021688
Marketing category: NDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: CINACALCET HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0578		I	Inactivated by FDA		2026-08-07
excluded package	package	53808-0578	53808-0578-1	I	Inactivated by FDA		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0578-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0578-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0578-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0578-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0578-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0578-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0578-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0578-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0578-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0578-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0578-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0578-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0578-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0578-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0578-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0578-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0578-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0578-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0578-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0578-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0578-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0578-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021688-001	SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	RLD	2004-03-08
N021688-002	SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	RLD	2004-03-08
N021688-003	SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	RLD	2004-03-08

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02
N021688-001	9375405	2026-09-22		Drug product	2016-07-22
N021688-002	7829595	2026-09-22	U-1098	Drug product
N021688-002	9375405	2026-09-22		Drug product	2016-07-22
N021688-003	7829595	2026-09-22	U-1098	Drug product
N021688-003	9375405	2026-09-22		Drug product	2016-07-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL		RLD	2004-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL		RLD	2004-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL		RLD	2004-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-002	SENSIPAR	EQ 60MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-003	SENSIPAR	EQ 90MG BASE	TABLET / ORAL	AB	RLD, RS	2004-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021688-001	SENSIPAR	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2004-03-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021688-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021688-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021688-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021688-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021688-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021688-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021688-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021688-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021688-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021688-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021688-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021688-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021688-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021688-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021688-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021688-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021688-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021688-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021688-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021688-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021688-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021688-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021688-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021688-001	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-002	7829595	2026-09-22	U-1098	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-003	7829595	2026-09-22	U-1098	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-002	7829595	2026-09-22	U-1098	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-003	7829595	2026-09-22	U-1098	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-002	7829595	2026-09-22	U-1098	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-003	7829595	2026-09-22	U-1098	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-002	7829595	2026-09-22	U-1098	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-003	7829595	2026-09-22	U-1098	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-002	7829595	2026-09-22	U-1098	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-003	7829595	2026-09-22	U-1098	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-002	7829595	2026-09-22	U-1098	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-003	7829595	2026-09-22	U-1098	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021688-003	9375405	2026-09-22		Drug product	2016-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	7829595	2026-09-22	U-1098	Drug product	2010-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-001	9375405	2026-09-22		Drug product	2016-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	7829595	2026-09-22	U-1098	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021688-002	9375405	2026-09-22		Drug product	2016-07-22	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021688-001	M-200	2020-05-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-001	ODE-78	2021-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-002	M-200	2020-05-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-002	ODE-78	2021-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-003	M-200	2020-05-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021688-003	ODE-78	2021-11-21	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021688-001	ODE-78	2021-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021688-002	ODE-78	2021-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021688-003	ODE-78	2021-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021688-001	ODE-78	2021-11-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021688-002	ODE-78	2021-11-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021688-003	ODE-78	2021-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021688-001	ODE-78	2021-11-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021688-002	ODE-78	2021-11-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021688-003	ODE-78	2021-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021688-001	M-200	2020-05-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-001	ODE-78	2021-11-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-002	M-200	2020-05-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-002	ODE-78	2021-11-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-003	M-200	2020-05-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021688-003	ODE-78	2021-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021688-001	M-200	2020-05-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-001	ODE-78	2021-11-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-002	M-200	2020-05-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-002	ODE-78	2021-11-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-003	M-200	2020-05-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021688-003	ODE-78	2021-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021688-001	M-200	2020-05-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-001	ODE-78	2021-11-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-002	M-200	2020-05-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-002	ODE-78	2021-11-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-003	M-200	2020-05-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021688-003	ODE-78	2021-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021688-001	M-200	2020-05-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-001	ODE-78	2021-11-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-002	M-200	2020-05-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-002	ODE-78	2021-11-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-003	M-200	2020-05-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021688-003	ODE-78	2021-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021688-001	M-200	2020-05-23	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03	Product name	3	20181011

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0578-1	2019-10-21	C162847	48780-1	956f9ecf-db6f-621f-e053-dbdaa90a74ad	Sensipar ® (cinacalcet) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0578-1	Sensipar	30 in 1 BLISTER PACK	TABLET, COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CINACALCET HYDROCHLORIDE	ACTIVE INGREDIENT	1K860WSG25	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CINACALCET	ACTIVE MOIETY	UAZ6V7728S	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0578	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100611_8f390187-1071-4000-b778-1d21c518cc9c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensipar	CINACALCET HYDROCHLORIDE	Amgen Inc	45028573-13c4-4c8b-ae62-6c75bba97c81	2025-12-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021688 application number: NDA021688

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K860WSG25	CINACALCET HYDROCHLORIDE	364782-34-3	CINACALCET HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
432402	cinacalcet HCl 30 MG Oral Tablet	PSN	8f390187-1071-4000-b778-1d21c518cc9c	1
432401	cinacalcet HCl 60 MG Oral Tablet	PSN	8f390187-1071-4000-b778-1d21c518cc9c	1
656137	Sensipar 30 MG Oral Tablet	PSN	8f390187-1071-4000-b778-1d21c518cc9c	1
706958	Sensipar 60 MG Oral Tablet	PSN	8f390187-1071-4000-b778-1d21c518cc9c	1
656137	cinacalcet 30 MG Oral Tablet [Sensipar]	SBD	8f390187-1071-4000-b778-1d21c518cc9c	1
706958	cinacalcet 60 MG Oral Tablet [Sensipar]	SBD	8f390187-1071-4000-b778-1d21c518cc9c	1
432402	cinacalcet 30 MG Oral Tablet	SCD	8f390187-1071-4000-b778-1d21c518cc9c	1
432401	cinacalcet 60 MG Oral Tablet	SCD	8f390187-1071-4000-b778-1d21c518cc9c	1
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	8f390187-1071-4000-b778-1d21c518cc9c	1
432401	cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral Tablet	SY	8f390187-1071-4000-b778-1d21c518cc9c	1
656137	Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral Tablet	SY	8f390187-1071-4000-b778-1d21c518cc9c	1
656137	Sensipar 30 MG Oral Tablet	SY	8f390187-1071-4000-b778-1d21c518cc9c	1
706958	Sensipar 60 MG (as cinacalcet hydrochloride 66 MG) Oral Tablet	SY	8f390187-1071-4000-b778-1d21c518cc9c	1
706958	Sensipar 60 MG Oral Tablet	SY	8f390187-1071-4000-b778-1d21c518cc9c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0578-1	53808057801	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sensipar ® (cinacalcet) Tablets	State of Florida DOH Central Pharmacy	2010-06-08	HUMAN PRESCRIPTION DRUG LABEL	1