Cinacalcet Hydrochloride

Product NDC: 65162-213
11-digit product format: 651620213
Labeler code: 65162
Product ID: 65162-213_4d63252a-b953-4066-b38c-a468580dc407
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cinacalcet
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA204364
Marketing category: ANDA
Marketing start: 2021-12-06
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	Approval date
A204364-001	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2021-12-02
A204364-002	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	2021-12-02
A204364-003	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET / ORAL	2021-12-02

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 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204364-002	CINACALCET HYDROCHLORIDE	60MG	TABLET / ORAL	2021-12-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204364-003	CINACALCET HYDROCHLORIDE	90MG	TABLET / ORAL	2021-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204364-001	CINACALCET HYDROCHLORIDE	30MG	TABLET / ORAL	2021-12-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A204364-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204364-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204364-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204364-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204364-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204364-003	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cinacalcet Hydrochloride
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
28262843-b0a8-4ca7-8b92-41b7f0e896b4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03	Product name	3	20181011
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-213-03	Cinacalcet Hydrochloride	30 in 1 BOTTLE	TABLET	30	16
65162-213-10	Cinacalcet Hydrochloride	100 in 1 BOTTLE	TABLET	100	16
65162-213-25	Cinacalcet Hydrochloride	250 in 1 BOTTLE	TABLET	250	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-213	CINACALCET HYDROCHLORIDE (CINACALCET) TABLET [AMNEAL PHARMACEUTICALS LLC]	16	Current NDC, Legacy NDC, 3 package rows	20241027_28262843-b0a8-4ca7-8b92-41b7f0e896b4.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 Hydrochloride	CINACALCET	Amneal Pharmaceuticals LLC	28262843-b0a8-4ca7-8b92-41b7f0e896b4	2021-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204364 application number: ANDA204364 ndc (product): 65162-213

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	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432401	cinacalcet HCl 60 MG Oral Tablet	PSN	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432400	cinacalcet HCl 90 MG Oral Tablet	PSN	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432402	cinacalcet 30 MG Oral Tablet	SCD	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432401	cinacalcet 60 MG Oral Tablet	SCD	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432400	cinacalcet 90 MG Oral Tablet	SCD	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432401	cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral Tablet	SY	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16
432400	cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral Tablet	SY	28262843-b0a8-4ca7-8b92-41b7f0e896b4	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-213-03	65162021303	30 TABLET in 1 BOTTLE (65162-213-03)	30 tablet	2021-12-06	0000-00-00	No	No	Current
65162-213-10	65162021310	100 TABLET in 1 BOTTLE (65162-213-10)	100 tablet	2021-12-06	0000-00-00	No	No	Current
65162-213-25	65162021325	250 TABLET in 1 BOTTLE (65162-213-25)	250 tablet	2021-12-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cinacalcet Hydrochloride	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2021-08-24	HUMAN PRESCRIPTION DRUG LABEL	16