Cinacalcet

Product NDC: 42543-963
11-digit product format: 425430963
Labeler code: 42543
Product ID: 42543-963_ebb3ed9d-c261-488e-97a1-940f63cd2a86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cinacalcet
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strides Pharma Inc.
Application: ANDA209226
Marketing category: ANDA
Marketing start: 2020-06-01
Marketing end: 0000-00-00
Substance: CINACALCET HYDROCHLORIDE
Active strength: 90 mg/1
Pharmacologic classes: Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	42543-963		D	Discontinued by firm		2026-08-11
excluded package	package	42543-963	42543-963-04	D	Discontinued by firm		2026-08-11

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 · 4 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	42543-963-04	`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	42543-963-04	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	TE codes	RLD / RS	Approval date
A209226-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30
A209226-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30
A209226-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209226-001	AB
A209226-002	AB
A209226-003	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 · 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	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	RS	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2018-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB		2018-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209226-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB		2018-04-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209226-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209226-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209226-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209226-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209226-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209226-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209226-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209226-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209226-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209226-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209226-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209226-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209226-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209226-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209226-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-963-04	EA - Each	42543-963	8239e166-7d65-4710-81fa-a5887c5e233e	1	2020-08-06

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cinacalcet	CINACALCET	REMEDYREPACK INC.	1c78bfff-7a82-4d1d-bc61-718c3ff3aa92	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226
Cinacalcet	CINACALCET	AvPAK	4d2f2a92-ee1c-084a-e063-6294a90aae96	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226
Cinacalcet	CINACALCET	Major Pharmaceuticals	0692252e-4cc6-4f16-8a54-aeacd59c3143	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226
Cinacalcet	CINACALCET	Strides Pharma Science Limited	0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d7	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226
Cinacalcet	CINACALCET	American Health Packaging	44b548ef-1679-4d15-86ad-0d9636b48a45	2025-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209226 application number: ANDA209226

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K860WSG25	CINACALCET HYDROCHLORIDE	364782-34-3	CINACALCET HYDROCHLORIDE
UAZ6V7728S	CINACALCET	226256-56-0	Cinacalcet

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-963-04	42543096304	30 TABLET, FILM COATED in 1 BOTTLE (42543-963-04)	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cinacalcet	Golden State Medical Supply, Inc.	2023-08-14	HUMAN PRESCRIPTION DRUG LABEL	5
Cinacalcet	Strides Pharma Inc. \| Strides Pharma Science Limited	2023-01-23	HUMAN PRESCRIPTION DRUG LABEL	2