CINACALCET

Product NDC: 76282-676
11-digit product format: 762820676
Labeler code: 76282
Product ID: 76282-676_d4eda09a-6371-49ea-bc20-054b55e432e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CINACALCET
Dosage form: TABLET
Route: ORAL
Labeler: EXELAN PHARMACEUTICALS INC.
Application: ANDA208915
Marketing category: ANDA
Marketing start: 2020-04-14
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: 2026-12-31
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	TE codes	Approval date
A208915-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08
A208915-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08
A208915-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208915-001	AB
A208915-002	AB
A208915-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208915-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208915-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208915-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`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	A208915-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208915-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208915-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208915-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208915-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208915-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208915-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208915-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208915-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208915-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208915-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208915-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208915-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208915-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208915-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208915-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208915-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208915-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208915-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208915-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208915-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208915-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208915-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208915-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208915-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208915-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208915-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208915-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208915-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208915-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208915-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208915-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208915-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208915-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208915-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208915-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208915-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208915-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208915-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208915-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: CINACALCET
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CINACALCET HYDROCHLORIDE	90 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
432400	Internal RxNorm lookup
432401	Internal RxNorm lookup
432402	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
04a978cb-d57b-4f1e-ba14-316b6f9abe33	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
76282-676-30	CINACALCET	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-676-30	EA - Each	76282-676	4b00ab88-4b5e-4964-8061-ba4f34c8f890	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-676	CINACALCET TABLET [EXELAN PHARMACEUTICALS INC.]	1	Current NDC, Legacy NDC, 1 package rows	20200415_04a978cb-d57b-4f1e-ba14-316b6f9abe33.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CINACALCET	CINACALCET	Bryant Ranch Prepack	f0604423-af02-46dd-b38b-8e0937517304	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208915 application number: ANDA208915
CINACALCET	CINACALCET	Cipla USA Inc.	02b8c11b-99e8-4039-b6fa-a9c38d2f48fa	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208915 application number: ANDA208915
CINACALCET	CINACALCET	Bryant Ranch Prepack	8b6b3867-9c89-4b6d-b381-dc73e1502821	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208915 application number: ANDA208915
CINACALCET	CINACALCET	Bryant Ranch Prepack	4a561936-494f-4320-bf6e-c36481f1518c	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208915 application number: ANDA208915
CINACALCET	CINACALCET	Bryant Ranch Prepack	93e94a24-fe2f-4ce6-bd1b-0d51be4e74bc	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208915 application number: ANDA208915
CINACALCET	CINACALCET	EXELAN PHARMACEUTICALS INC.	04a978cb-d57b-4f1e-ba14-316b6f9abe33	2020-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208915 application number: ANDA208915 ndc (product): 76282-676

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
432402	cinacalcet HCl 30 MG Oral Tablet	PSN	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432401	cinacalcet HCl 60 MG Oral Tablet	PSN	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432400	cinacalcet HCl 90 MG Oral Tablet	PSN	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432402	cinacalcet 30 MG Oral Tablet	SCD	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432401	cinacalcet 60 MG Oral Tablet	SCD	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432400	cinacalcet 90 MG Oral Tablet	SCD	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432401	cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral Tablet	SY	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1
432400	cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral Tablet	SY	04a978cb-d57b-4f1e-ba14-316b6f9abe33	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-676-30	76282067630	30 TABLET in 1 BOTTLE (76282-676-30)	30 tablet	2020-04-14	0000-00-00	No	No	Current