Darifenacin

Product NDC: 13668-202
11-digit product format: 136680202
Labeler code: 13668
Product ID: 13668-202_fe809224-0deb-4a82-b454-054be6dd4931
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Darifenacin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA205209
Marketing category: ANDA
Marketing start: 2016-11-18
Substance: DARIFENACIN HYDROBROMIDE
Active strength: 7.5 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [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 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
A205209-001	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-11-17
A205209-002	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-11-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205209-001	AB
A205209-002	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 3 · 84 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	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205209-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205209-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A205209-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205209-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205209-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205209-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205209-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205209-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205209-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205209-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205209-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205209-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205209-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205209-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205209-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205209-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205209-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205209-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205209-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205209-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205209-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205209-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205209-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205209-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205209-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205209-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205209-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205209-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205209-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205209-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205209-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205209-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205209-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205209-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205209-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205209-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205209-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205209-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205209-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205209-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205209-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205209-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DARIFENACIN HYDROBROMIDE	7.5 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
e84f1ae3-b9a2-4a15-a299-c75373891cc1	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
13668-202-05	Darifenacin	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	10
13668-202-30	Darifenacin	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	10
13668-202-90	Darifenacin	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-202-30	EA - Each	13668-202	05d83bff-c2f1-4456-be87-7a52afcba0e3	1	2017-08-11
13668-202-90	EA - Each	13668-202	729df6fa-c45f-43f7-a13e-dda961c823de	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-202	DARIFENACIN TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	9	Current NDC, Legacy NDC, 3 package rows	20250426_e84f1ae3-b9a2-4a15-a299-c75373891cc1.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Darifenacin	DARIFENACIN	Torrent Pharmaceuticals Limited	e84f1ae3-b9a2-4a15-a299-c75373891cc1	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205209 application number: ANDA205209 ndc (product): 13668-202
Darifenacin	DARIFENACIN	Bryant Ranch Prepack	697eba55-9e1f-4036-baed-5644c810f166	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205209 application number: ANDA205209
Darifenacin	DARIFENACIN	Bryant Ranch Prepack	5ac2cb5a-c0bb-40e2-95d5-1b91a13036c3	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205209 application number: ANDA205209

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CR02EYQ8GV	DARIFENACIN HYDROBROMIDE	133099-07-7	DARIFENACIN HYDROBROMIDE
APG9819VLM	DARIFENACIN	133099-04-4	Darifenacin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485423	darifenacin 7.5 MG 24HR Extended Release Oral Tablet	PSN	697eba55-9e1f-4036-baed-5644c810f166	100
485423	24 HR darifenacin 7.5 MG Extended Release Oral Tablet	SCD	697eba55-9e1f-4036-baed-5644c810f166	100
485423	darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral Tablet	SY	697eba55-9e1f-4036-baed-5644c810f166	100
485421	darifenacin 15 MG 24HR Extended Release Oral Tablet	PSN	e84f1ae3-b9a2-4a15-a299-c75373891cc1	10
485423	darifenacin 7.5 MG 24HR Extended Release Oral Tablet	PSN	e84f1ae3-b9a2-4a15-a299-c75373891cc1	10
485421	24 HR darifenacin 15 MG Extended Release Oral Tablet	SCD	e84f1ae3-b9a2-4a15-a299-c75373891cc1	10
485423	24 HR darifenacin 7.5 MG Extended Release Oral Tablet	SCD	e84f1ae3-b9a2-4a15-a299-c75373891cc1	10
485421	darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral Tablet	SY	e84f1ae3-b9a2-4a15-a299-c75373891cc1	10
485423	darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral Tablet	SY	e84f1ae3-b9a2-4a15-a299-c75373891cc1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-202-05	13668020205	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05)	2016-11-18	0000-00-00	No	No	Current
13668-202-30	13668020230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30)	2016-11-18	0000-00-00	No	No	Current
13668-202-74	13668020274	100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-202-74)	2016-11-18	0000-00-00	No	No	Current
13668-202-90	13668020290	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-90)	2016-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Darifenacin	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	10
Darifenacin	Bryant Ranch Prepack	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	100