Sensipar

Product NDC: 50090-4470
11-digit product format: 500904470
Labeler code: 50090
Product ID: 50090-4470_a261c7fd-485e-4cfe-b8fa-bde13855fcca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cinacalcet hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021688
Marketing category: NDA
Marketing start: 2004-04-04
Marketing end: 0000-00-00
Substance: CINACALCET HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50090-4470		D	Discontinued by firm		2026-08-07
excluded package	package	50090-4470	50090-4470-0	D	Discontinued by firm		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 · 24 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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`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	50090-4470-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4470-0	2023-02-07	C162847	48780-1	f386c649-eda2-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SENSIPAR safely and effectively. See full prescribing information for SENSIPAR . SENSIPAR ® (cinacalcet) tablets, for oral use Initial U.S. Approval: 2004
50090-4470-0	2023-01-30	C162847	48780-1	f386c649-eda2-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SENSIPAR safely and effectively. See full prescribing information for SENSIPAR . SENSIPAR ® (cinacalcet) tablets, for oral use Initial U.S. Approval: 2004

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4470-0	50090447000	30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-4470-0)	2019-08-19	0000-00-00	No	No	Current