Alfuzosin Hydrochloride

Product NDC: 71335-2578
11-digit product format: 713352578
Labeler code: 71335
Product ID: 71335-2578_7ce6f1ee-cf32-445d-a682-b01823587446
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alfuzosin Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
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: 2027-12-31
Current FDA listing: Yes

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
37e89394-af6e-4700-bfa8-2effba1a286b	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
71335-2578-1	Alfuzosin Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	2
71335-2578-2	Alfuzosin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	2
71335-2578-3	Alfuzosin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	2
71335-2578-4	Alfuzosin Hydrochloride	120 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	120	2
71335-2578-5	Alfuzosin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2578	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1	Current NDC, 5 package rows	20250209_37e89394-af6e-4700-bfa8-2effba1a286b.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
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 ndc (product): 71335-2578
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	37e89394-af6e-4700-bfa8-2effba1a286b	2
861132	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet	SCD	37e89394-af6e-4700-bfa8-2effba1a286b	2
861132	alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet	SY	37e89394-af6e-4700-bfa8-2effba1a286b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2578-1	71335257801	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-1)	2025-02-06	No	No	Current
71335-2578-2	71335257802	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-2)	2025-02-06	No	No	Current
71335-2578-3	71335257803	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-3)	2025-02-06	No	No	Current
71335-2578-4	71335257804	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-4)	2025-02-06	No	No	Current
71335-2578-5	71335257805	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-5)	2025-02-06	No	No	Current