Darifenacin 7.5 mg

Product NDC: 70700-182
Requested package NDC: 70700-182-30
11-digit product format: 707000182
Labeler code: 70700
Product ID: 70700-182_045ab360-9ad8-5d11-f670-a97c2604cb1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Darifenacin Hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Xiromed, LLC
Application: ANDA209571
Marketing category: ANDA
Marketing start: 2021-04-30
Marketing end: 0000-00-00
Substance: DARIFENACIN HYDROBROMIDE
Active strength: 8 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	70700-182	70700-182-30	I	Inactivated by FDA		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 · 9 matching rows.

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

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

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 Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70700-182-30	2025-01-30	C162847	48780-1	2cef2736-7816-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
70700-182-90	2025-01-30	C162847	48780-1	2cef2736-7816-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70700-182-30	Darifenacin 7.5 mg	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1
70700-182-90	Darifenacin 7.5 mg	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70700-182-30	EA - Each	70700-182	b4ab5992-520e-4895-9b0b-b2b68212fc06	1	2021-05-05
70700-182-90	EA - Each	70700-182	422242d7-9d6a-47fc-9b14-ab0f0f1af246	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70700-182	DARIFENACIN 7.5 MG (DARIFENACIN HYDROBROMIDE) TABLET, EXTENDED RELEASE DARIFENACIN 15 MG (DARIFENACIN HYDROBROMIDE) TABLET, EXTENDED RELEASE [XIROMED, LLC ]	1	Legacy NDC, 2 package rows	20210501_7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a.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	7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a	1
485423	darifenacin 7.5 MG 24HR Extended Release Oral Tablet	PSN	7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a	1
485421	24 HR darifenacin 15 MG Extended Release Oral Tablet	SCD	7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a	1
485423	24 HR darifenacin 7.5 MG Extended Release Oral Tablet	SCD	7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a	1
485421	darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral Tablet	SY	7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a	1
485423	darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral Tablet	SY	7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70700-182-30	70700018230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70700-182-30)	2021-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Darifenacin 7.5 mg	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	2
Darifenacin 7.5 mg	Xiromed, LLC \| Xiromed Pharma España, S.L \| AustarPharma, LLC	2021-04-30	HUMAN PRESCRIPTION DRUG LABEL	1