Sensipar

Product NDC: 55513-073
11-digit product format: 555130073
Labeler code: 55513
Product ID: 55513-073_42c2c9c2-6929-4952-b559-a57a1d75424e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cinacalcet hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Amgen Inc
Application: NDA021688
Marketing category: NDA
Marketing start: 2004-04-04
Marketing end: 2027-12-31
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
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sensipar

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CINACALCET HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K860WSG25	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
432400	Internal RxNorm lookup
432401	Internal RxNorm lookup
432402	Internal RxNorm lookup
656137	Internal RxNorm lookup
706958	Internal RxNorm lookup
706960	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45028573-13c4-4c8b-ae62-6c75bba97c81	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55513-073-30	Sensipar	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30		136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-073-30	EA - Each	55513-073	13729216-5316-4ece-88b6-dc690d9941d5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CINACALCET HYDROCHLORIDE	ACTIVE INGREDIENT	1K860WSG25	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
CINACALCET	ACTIVE MOIETY	UAZ6V7728S	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	124
CINACALCET HYDROCHLORIDE	ACTIVE INGREDIENT	1K860WSG25	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
CINACALCET	ACTIVE MOIETY	UAZ6V7728S	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]	2
CINACALCET HYDROCHLORIDE	ACTIVE INGREDIENT	1K860WSG25	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CINACALCET HYDROCHLORIDE	ACTIVE INGREDIENT	1K860WSG25	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
CINACALCET	ACTIVE MOIETY	UAZ6V7728S	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CINACALCET	ACTIVE MOIETY	UAZ6V7728S	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	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 [PHYSICIANS TOTAL CARE, INC.]	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
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	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 [PHYSICIANS TOTAL CARE, INC.]	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
55513-073	SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]	135	Current NDC, Legacy NDC, 1 package rows	20241115_45028573-13c4-4c8b-ae62-6c75bba97c81.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 ndc (product): 55513-073

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	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432401	cinacalcet HCl 60 MG Oral Tablet	PSN	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432400	cinacalcet HCl 90 MG Oral Tablet	PSN	45028573-13c4-4c8b-ae62-6c75bba97c81	136
656137	Sensipar 30 MG Oral Tablet	PSN	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706958	Sensipar 60 MG Oral Tablet	PSN	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706960	Sensipar 90 MG Oral Tablet	PSN	45028573-13c4-4c8b-ae62-6c75bba97c81	136
656137	cinacalcet 30 MG Oral Tablet [Sensipar]	SBD	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706958	cinacalcet 60 MG Oral Tablet [Sensipar]	SBD	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706960	cinacalcet 90 MG Oral Tablet [Sensipar]	SBD	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432402	cinacalcet 30 MG Oral Tablet	SCD	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432401	cinacalcet 60 MG Oral Tablet	SCD	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432400	cinacalcet 90 MG Oral Tablet	SCD	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432401	cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432400	cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706960	Sensipar (cinacalcet 90 MG) Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
656137	Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
656137	Sensipar 30 MG Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706958	Sensipar 60 MG (as cinacalcet hydrochloride 66 MG) Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706958	Sensipar 60 MG Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
706960	Sensipar 90 MG Oral Tablet	SY	45028573-13c4-4c8b-ae62-6c75bba97c81	136
432402	cinacalcet HCl 30 MG Oral Tablet	PSN	8ff022bc-4627-4965-beb1-968deb5b56bc	3
656137	Sensipar 30 MG Oral Tablet	PSN	8ff022bc-4627-4965-beb1-968deb5b56bc	3
656137	cinacalcet 30 MG Oral Tablet [Sensipar]	SBD	8ff022bc-4627-4965-beb1-968deb5b56bc	3
432402	cinacalcet 30 MG Oral Tablet	SCD	8ff022bc-4627-4965-beb1-968deb5b56bc	3
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	8ff022bc-4627-4965-beb1-968deb5b56bc	3
656137	Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral Tablet	SY	8ff022bc-4627-4965-beb1-968deb5b56bc	3
656137	Sensipar 30 MG Oral Tablet	SY	8ff022bc-4627-4965-beb1-968deb5b56bc	3
432402	cinacalcet HCl 30 MG Oral Tablet	PSN	c94c1206-97cb-4088-b8a1-adf08b938755	1
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	c94c1206-97cb-4088-b8a1-adf08b938755	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
656137	cinacalcet 30 MG Oral Tablet [Sensipar]	SBD	c94c1206-97cb-4088-b8a1-adf08b938755	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
432402	cinacalcet 30 MG Oral Tablet	SCD	c94c1206-97cb-4088-b8a1-adf08b938755	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
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	c94c1206-97cb-4088-b8a1-adf08b938755	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	c94c1206-97cb-4088-b8a1-adf08b938755	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
656137	Sensipar 30 MG Oral Tablet	SY	c94c1206-97cb-4088-b8a1-adf08b938755	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	Marketing start	Marketing end	Sample	Exclude flag	Status
55513-073-30	55513007330	30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-073-30)	2004-04-04	2027-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sensipar	Amgen Inc	2025-12-07	HUMAN PRESCRIPTION DRUG LABEL	136
Sensipar	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	5
Sensipar	A-S Medication Solutions	2019-08-29	HUMAN PRESCRIPTION DRUG LABEL	2
Sensipar	Carilion Materials Management	2016-08-06	HUMAN PRESCRIPTION DRUG LABEL	3
Sensipar	Physicians Total Care, Inc.	2012-05-01	HUMAN PRESCRIPTION DRUG LABEL	1
Sensipar ® (cinacalcet) Tablets	State of Florida DOH Central Pharmacy	2010-06-08	HUMAN PRESCRIPTION DRUG LABEL	1