Alfuzosin Hydrochloride

Product NDC: 84386-153
11-digit product format: 843860153
Labeler code: 84386
Product ID: 84386-153_8811cb59-6826-41d5-ab68-567338a4b883
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: 2026-07-01
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079060-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079060-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079060-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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
8811cb59-6826-41d5-ab68-567338a4b883	Available on FDA.report

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
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 ndc (product): 84386-153
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84386-153-01	84386015301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-01)	2026-07-01	No	No	Current
84386-153-05	84386015305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-05)	2026-07-01	No	No	Current
84386-153-30	84386015330	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-30)	2026-07-01	No	No	Current
84386-153-90	84386015390	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-90)	2026-07-01	No	No	Current
84386-153-99	84386015399	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-99)	2026-07-01	No	No	Current