Cinacalcet Hydrochloride

Product NDC: 0591-2416
11-digit product format: 005912416
Labeler code: 0591
Product ID: 0591-2416_c0e98237-6c99-4402-942b-e702073f1feb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cinacalcet Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA204377
Marketing category: ANDA
Marketing start: 2018-12-27
Marketing end: 2020-06-30
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: 0000-00-00
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	0591-2416		D	Discontinued by firm		2026-10-20
excluded package	package	0591-2416	0591-2416-30	D	Discontinued by firm		2026-10-20

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-2416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0591-2416-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0591-2416-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0591-2416-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
A204377-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27
A204377-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27
A204377-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204377-001	AB
A204377-002	AB
A204377-003	AB

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204377-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204377-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204377-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-12-27	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A204377-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204377-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204377-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204377-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204377-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204377-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204377-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204377-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204377-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204377-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204377-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204377-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204377-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204377-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204377-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204377-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204377-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204377-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204377-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204377-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204377-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204377-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204377-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204377-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204377-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204377-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204377-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204377-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204377-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204377-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204377-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204377-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204377-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204377-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204377-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204377-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204377-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204377-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204377-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204377-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2416-30	EA - Each	0591-2416	c1ae23ea-8e2d-4efd-91f6-4d35a7b29146	1	2019-02-13