Darifenacin

Product NDC: 16571-768
11-digit product format: 165710768
Labeler code: 16571
Product ID: 16571-768_fd55c56a-79a8-4830-92d7-19f62bee0b5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Darifenacin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA206743
Marketing category: ANDA
Marketing start: 2016-09-19
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
A206743-001	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-19
A206743-002	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206743-001	AB
A206743-002	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	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206743-001	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206743-002	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-19	`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	A206743-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206743-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206743-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206743-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206743-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206743-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206743-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206743-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206743-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206743-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206743-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206743-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206743-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206743-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206743-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206743-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206743-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206743-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206743-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206743-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206743-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206743-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206743-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206743-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206743-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206743-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206743-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206743-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206743-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206743-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206743-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206743-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206743-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206743-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206743-002	AB	1	`bb7c543d1eb4…`

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
e2aa9544-0136-463d-a73b-1a299534446a	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	Strength	SPL version
16571-768-03	Darifenacin	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		2
16571-768-09	Darifenacin	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-768-03	EA - Each	16571-768	cc0f51a4-8dc0-479d-8d15-0f0054f6bfa5	1	2022-03-09
16571-768-09	EA - Each	16571-768	c1847660-4920-4e29-889a-7b3ac3a03091	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-768	DARIFENACIN TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240501_e2aa9544-0136-463d-a73b-1a299534446a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Darifenacin	DARIFENACIN	Aurobindo Pharma Limited	28ed5b58-46dd-4140-a877-4b422f780a94	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206743 application number: ANDA206743
Darifenacin	DARIFENACIN	Rising Pharma Holdings, Inc.	e2aa9544-0136-463d-a73b-1a299534446a	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206743 application number: ANDA206743 ndc (product): 16571-768

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
485421	darifenacin 15 MG 24HR Extended Release Oral Tablet	PSN	e2aa9544-0136-463d-a73b-1a299534446a	2
485423	darifenacin 7.5 MG 24HR Extended Release Oral Tablet	PSN	e2aa9544-0136-463d-a73b-1a299534446a	2
485421	24 HR darifenacin 15 MG Extended Release Oral Tablet	SCD	e2aa9544-0136-463d-a73b-1a299534446a	2
485423	24 HR darifenacin 7.5 MG Extended Release Oral Tablet	SCD	e2aa9544-0136-463d-a73b-1a299534446a	2
485421	darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral Tablet	SY	e2aa9544-0136-463d-a73b-1a299534446a	2
485423	darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral Tablet	SY	e2aa9544-0136-463d-a73b-1a299534446a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-768-03	16571076803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-03)	2016-09-19	0000-00-00	No	No	Current
16571-768-09	16571076809	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-09)	2016-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Darifenacin	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-04-19	Human Prescription Drug Label	2