Cinacalcet

Product NDC: 65862-832
Requested package NDC: 65862-832-90
11-digit product format: 658620832
Labeler code: 65862
Product ID: 65862-832_5aadf0b6-2c49-48d4-8d22-2fbf99dbf4e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cinacalcet
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA206125
Marketing category: ANDA
Marketing start: 2019-06-25
Substance: CINACALCET HYDROCHLORIDE
Active strength: 60 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65862-832	65862-832-90	D	Discontinued by firm		2026-08-11

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
A206125-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08
A206125-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08
A206125-003	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
A206125-001	AB
A206125-002	AB
A206125-003	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	A206125-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206125-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206125-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206125-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206125-001	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2018-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206125-002	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	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	A206125-001	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	A206125-002	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	A206125-003	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	AB	2018-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206125-001	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	A206125-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206125-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206125-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206125-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206125-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206125-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206125-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206125-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206125-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206125-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206125-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206125-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206125-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206125-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206125-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206125-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206125-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206125-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206125-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206125-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206125-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206125-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206125-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206125-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206125-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206125-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206125-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206125-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206125-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206125-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206125-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206125-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206125-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206125-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206125-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206125-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206125-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206125-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206125-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206125-001	AB	1	`8072bd15b7f6…`

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	SPL version
65862-832-01	Cinacalcet	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
65862-832-05	Cinacalcet	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
65862-832-30	Cinacalcet	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
65862-832-90	Cinacalcet	90 in 1 BOTTLE	TABLET, FILM COATED	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-832-05	EA - Each	65862-832	e038c033-5989-4758-b714-2b5375bb231c	1	2021-10-08
65862-832-30	EA - Each	65862-832	478f1b94-c679-470e-9e27-7f7dd4eda9ca	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-832	CINACALCET TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9	Current NDC, Legacy NDC, 4 package rows	20240220_42e99112-c402-4662-877f-9e3a84dff9f2.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
Cinacalcet	CINACALCET	Aurobindo Pharma Limited	200390f2-7dad-4ecc-a086-c29e18525c01	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206125 application number: ANDA206125

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	42e99112-c402-4662-877f-9e3a84dff9f2	9
432401	cinacalcet HCl 60 MG Oral Tablet	PSN	42e99112-c402-4662-877f-9e3a84dff9f2	9
432400	cinacalcet HCl 90 MG Oral Tablet	PSN	42e99112-c402-4662-877f-9e3a84dff9f2	9
432402	cinacalcet 30 MG Oral Tablet	SCD	42e99112-c402-4662-877f-9e3a84dff9f2	9
432401	cinacalcet 60 MG Oral Tablet	SCD	42e99112-c402-4662-877f-9e3a84dff9f2	9
432400	cinacalcet 90 MG Oral Tablet	SCD	42e99112-c402-4662-877f-9e3a84dff9f2	9
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	42e99112-c402-4662-877f-9e3a84dff9f2	9
432401	cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral Tablet	SY	42e99112-c402-4662-877f-9e3a84dff9f2	9
432400	cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral Tablet	SY	42e99112-c402-4662-877f-9e3a84dff9f2	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-832-90	65862083290	90 TABLET, FILM COATED in 1 BOTTLE (65862-832-90)	2019-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cinacalcet	Aurobindo Pharma Limited \| Appco Pharma LLC	2024-02-19	Human Prescription Drug Label	9
Cinacalcet	AvKARE	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	4