Cinacalcet

Product NDC: 50268-188
Requested package NDC: 50268-188-12
11-digit product format: 502680188
Labeler code: 50268
Product ID: 50268-188_4d2f2aa7-d529-e8e9-e063-6294a90aab14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cinacalcet
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA209226
Marketing category: ANDA
Marketing start: 2026-03-16
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: 2027-12-31
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	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cinacalcet
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CINACALCET HYDROCHLORIDE	30 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4d2f2a92-ee1c-084a-e063-6294a90aae96	Available on FDA.report

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	Strength	SPL version
50268-188-11	Cinacalcet	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		1
50268-188-12	Cinacalcet	20 in 1 BOX	TABLET, FILM COATED	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-188-11	EA - Each	50268-188	e8268434-0938-4a42-9a6d-eb018a6122df	1	2026-04-20
50268-188-12	EA - Each	50268-188	6060dd6a-0d13-4a19-ae91-940c77988650	1	2026-04-20

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 ndc (package): 50268-188-12 ndc (product): 50268-188 ndc11 (package): 50268018812
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
432402	cinacalcet HCl 30 MG Oral Tablet	PSN	4d2f2a92-ee1c-084a-e063-6294a90aae96	1
432402	cinacalcet 30 MG Oral Tablet	SCD	4d2f2a92-ee1c-084a-e063-6294a90aae96	1
432402	cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet	SY	4d2f2a92-ee1c-084a-e063-6294a90aae96	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-188-12	50268018812	20 BLISTER PACK in 1 BOX (50268-188-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-188-11)	20 blister pack	2026-03-16	No	No	Current