Alfuzosin hydrochloride

Product NDC: 0440-5000
11-digit product format: 004405000
Labeler code: 0440
Product ID: 0440-5000_a588f193-6be7-4048-bb99-970d8925c760
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alfuzosin hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Liberty Pharmaceuticals, Inc.
Application: ANDA090284
Marketing category: ANDA
Marketing start: 2012-10-02
Marketing end: 0000-00-00
Substance: ALFUZOSIN HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0440-5000		I	Inactivated by FDA		2026-08-03
excluded package	package	0440-5000	0440-5000-90	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0440-5000-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0440-5000-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0440-5000-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0440-5000-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0440-5000-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0440-5000-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0440-5000-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0440-5000-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0440-5000-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0440-5000-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0440-5000-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0440-5000-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0440-5000-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0440-5000-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0440-5000-90	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0440-5000-90	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0440-5000-90	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0440-5000-90	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0440-5000-90	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0440-5000-90	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0440-5000-90	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0440-5000-90	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090284-001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2012-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090284-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090284-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090284-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090284-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090284-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090284-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090284-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090284-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090284-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090284-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090284-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090284-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090284-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090284-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090284-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090284-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090284-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090284-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090284-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090284-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090284-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090284-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090284-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090284-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090284-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090284-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090284-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090284-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090284-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090284-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090284-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090284-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090284-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090284-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090284-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090284-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090284-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090284-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090284-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090284-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090284-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8b671e1a-6f8a-5de4-69a7-83132df7952d	Product name	3	20201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0440-5000-90	2020-01-31	C162847	48780-1	9d75b9cf-f4d0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0440-5000-90	Alfuzosin hydrochloride	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
0440-5000-90	EA - Each	0440-5000	975d7d41-9229-42be-b9dd-c7ba33028e3f	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0440-5000	ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [LIBERTY PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20160810_8a677905-e66d-44f7-b564-6c561387ed03.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
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	f075a897-7bef-4799-b7e2-7e051c461443	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090284 application number: ANDA090284
Alfuzosin Hydrochloride extended release	ALFUZOSIN HYDROCHLORIDE	Cipla USA Inc.	3cc028d5-309f-4ce3-a2d7-5804ab57677d	2020-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090284 application number: ANDA090284
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	790fe381-4a83-402e-b6c0-2ecde9cac7a7	2017-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090284 application number: ANDA090284

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
75046A1XTN	ALFUZOSIN HYDROCHLORIDE	81403-68-1	ALFUZOSIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861132	alfuzosin HCl 10 MG 24HR Extended Release Oral Tablet	PSN	8a677905-e66d-44f7-b564-6c561387ed03	1
861132	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet	SCD	8a677905-e66d-44f7-b564-6c561387ed03	1
861132	alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet	SY	8a677905-e66d-44f7-b564-6c561387ed03	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0440-5000-90	00440500090	90 in 1 BOTTLE	Historical