Darifenacin 15 mg

Product NDC: 71205-901
Requested package NDC: 71205-901-90
11-digit product format: 712050901
Labeler code: 71205
Product ID: 71205-901_9c01bd10-78e5-4785-858e-ececd310fb3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Darifenacin Hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA209571
Marketing category: ANDA
Marketing start: 2021-04-30
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	71205-901	71205-901-90	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209571-001	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL			2019-10-22
A209571-002	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL			2019-10-22

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
2026-10-15 13:18:30	2026-09	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		2019-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	BX	2019-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	BX	2019-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	BX	2019-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	BX	2019-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209571-001	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	BX	2019-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209571-002	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	BX	2019-10-22	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209571-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209571-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209571-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209571-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209571-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209571-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209571-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209571-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209571-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209571-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209571-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209571-002	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209571-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209571-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209571-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209571-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209571-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209571-002	AB	1	`8869cabd3fbd…`
2019-12-14 00:12 UTC	2019-12	A209571-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209571-002	AB	1	`3f01610625f2…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209571-001	BX	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209571-002	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209571-001	BX	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209571-002	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209571-001	BX	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A209571-002	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209571-001	BX	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209571-002	BX	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-901-00	EA - Each	71205-901	67f609f8-a38c-4702-a8d9-a68aee17fd77	1	2021-08-05
71205-901-11	EA - Each	71205-901	0f73b741-c13e-47eb-ac46-9b9cc051ff7e	1	2021-08-05
71205-901-30	EA - Each	71205-901	e8161d30-d9a9-4275-99d1-f23ce10cccee	1	2021-08-05
71205-901-55	EA - Each	71205-901	1ed3de55-ac35-4fab-830d-9313056f1d05	1	2021-08-05
71205-901-60	EA - Each	71205-901	bc1b9ba1-bcbb-4a86-9209-9bb85f155073	1	2021-08-05
71205-901-72	EA - Each	71205-901	ba3d0540-7532-43e3-9e04-4f5bdcd68877	1	2021-08-05
71205-901-90	EA - Each	71205-901	1ba88beb-1e3c-437a-a8cb-1b8739bdd471	1	2021-08-05

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-901-90	71205090190	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-901-90)	2021-07-21	0000-00-00	No	No	Current