Darifenacin

Product NDC: 52605-068
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
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 76 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
2026-08-18 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…`
2021-12-28 21:50 UTC	2021-12	A211045-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211045-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A211045-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211045-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DARIFENACIN HYDROBROMIDE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CR02EYQ8GV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485421	Internal RxNorm lookup
485423	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
62a72d3e-3c33-4f2d-b3d0-2e014f704c63	Available on FDA.report

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	Current NDC, Legacy NDC, 3 package rows	20221214_62a72d3e-3c33-4f2d-b3d0-2e014f704c63.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
Darifenacin	DARIFENACIN HYDROBROMIDE	POLYGEN PHARMACEUTICALS INC.	62a72d3e-3c33-4f2d-b3d0-2e014f704c63	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211045 application number: ANDA211045 ndc (product): 52605-068

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
52605-068-10	52605006810	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-10)	2020-12-01	0000-00-00	No	No	Current
52605-068-13	52605006813	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-13)	2020-12-01	0000-00-00	No	No	Current
52605-068-19	52605006819	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-19)	2020-12-01	0000-00-00	No	No	Current