Alfuzosin Hydrochloride

Product NDC: 65862-249
11-digit product format: 658620249
Labeler code: 65862
Product ID: 65862-249_d8c832c1-9455-4647-822a-ee4f35ba0560
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alfuzosin Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA079060
Marketing category: ANDA
Marketing start: 2012-08-30
Substance: ALFUZOSIN HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished product	product	65862-249		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	65862-249	65862-249-26	UNFINISHED	Active or certified unfinished drug listing		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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-249-26	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-249-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-249-26	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-249-26	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-249-26	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-249-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-249-26	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-249-26	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-249-26	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-249-26	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-249-26	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-249-26	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-249-26	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-249-26	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-249-26	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-249-26	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-249-26	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-249-26	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-249-26	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-249-26	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-249-26	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A079060-001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2012-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079060-001	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	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`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	A079060-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079060-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079060-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079060-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079060-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079060-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079060-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079060-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079060-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079060-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079060-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079060-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079060-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079060-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079060-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079060-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079060-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079060-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079060-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079060-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079060-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079060-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079060-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079060-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079060-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079060-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079060-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079060-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079060-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079060-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079060-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079060-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079060-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079060-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079060-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079060-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079060-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079060-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079060-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079060-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALFUZOSIN HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
75046A1XTN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861132	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
d163369b-e44b-4591-b166-7ddd0c1c13c0	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-249-01	Alfuzosin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	13
65862-249-05	Alfuzosin Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	13
65862-249-30	Alfuzosin Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	13
65862-249-90	Alfuzosin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	13
65862-249-99	Alfuzosin Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-249-01	EA - Each	65862-249	595c955f-086c-4e61-a22a-4823b5607d3c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALFUZOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	75046A1XTN	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
ALFUZOSIN	ACTIVE MOIETY	90347YTW5F	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-249	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	13	Current NDC, Legacy NDC, 5 package rows	20240109_d163369b-e44b-4591-b166-7ddd0c1c13c0.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	d163369b-e44b-4591-b166-7ddd0c1c13c0	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079060 application number: ANDA079060 ndc (product): 65862-249
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	8811cb59-6826-41d5-ab68-567338a4b883	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079060 application number: ANDA079060
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	37e89394-af6e-4700-bfa8-2effba1a286b	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079060 application number: ANDA079060
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	43675e9d-a361-4109-9ae1-54d80580fbbd	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079060 application number: ANDA079060
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Northwind Health Company, LLC	f2a530bd-6a86-251d-e053-2995a90adac4	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079060 application number: ANDA079060

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	d163369b-e44b-4591-b166-7ddd0c1c13c0	13
861132	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet	SCD	d163369b-e44b-4591-b166-7ddd0c1c13c0	13
861132	alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet	SY	d163369b-e44b-4591-b166-7ddd0c1c13c0	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-249-01	65862024901	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-01)	2012-08-30	0000-00-00	No	No	Current
65862-249-05	65862024905	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-05)	2012-08-30	0000-00-00	No	No	Current
65862-249-26	65862024926	2500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (65862-249-26)	30-AUG-12				Current
65862-249-30	65862024930	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-30)	2012-08-30	0000-00-00	No	No	Current
65862-249-90	65862024990	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-90)	2012-08-30	0000-00-00	No	No	Current
65862-249-99	65862024999	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-99)	2012-08-30	0000-00-00	No	No	Current