Darifenacin

Product NDC: 52605-068
Requested package NDC: 52605-068-13
11-digit product format: 526050068
Labeler code: 52605
Product ID: 52605-068_46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Darifenacin Hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: POLYGEN PHARMACEUTICALS INC.
Application: ANDA211045
Marketing category: ANDA
Marketing start: 2020-12-01
Marketing end: 0000-00-00
Substance: DARIFENACIN HYDROBROMIDE
Active strength: 15 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52605-068	52605-068-13	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211045-001	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2020-01-06
A211045-002	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2020-01-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211045-001	AB
A211045-002	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 2 · 78 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
2026-09-14 22:38:34	2026-08	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211045-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211045-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211045-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211045-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211045-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211045-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211045-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211045-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211045-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211045-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211045-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211045-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211045-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211045-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211045-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211045-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211045-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211045-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211045-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211045-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211045-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211045-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211045-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211045-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211045-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211045-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211045-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211045-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211045-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211045-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211045-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211045-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211045-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211045-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211045-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211045-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211045-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211045-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211045-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211045-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a92d88f6-1aad-c4c8-f6bc-f9f74c3d7bb2	Product name	7	20200407

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52605-068-10	Darifenacin	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	3
52605-068-13	Darifenacin	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	3
52605-068-19	Darifenacin	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52605-068	DARIFENACIN (DARIFENACIN HYDROBROMIDE) TABLET, EXTENDED RELEASE [POLYGEN PHARMACEUTICALS INC.]	3	Legacy NDC, 3 package rows	20221214_62a72d3e-3c33-4f2d-b3d0-2e014f704c63.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CR02EYQ8GV	DARIFENACIN HYDROBROMIDE	133099-07-7	DARIFENACIN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485421	darifenacin 15 MG 24HR Extended Release Oral Tablet	PSN	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	3
485423	darifenacin 7.5 MG 24HR Extended Release Oral Tablet	PSN	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	3
485421	24 HR darifenacin 15 MG Extended Release Oral Tablet	SCD	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	3
485423	24 HR darifenacin 7.5 MG Extended Release Oral Tablet	SCD	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	3
485421	darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral Tablet	SY	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	3
485423	darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral Tablet	SY	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52605-068-13	52605006813	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-13)	2020-12-01	0000-00-00	No	No	Current