Alfuzosin Hydrochloride

Product NDC: 51655-087
Requested package NDC: 51655-087-52
11-digit product format: 516550087
Labeler code: 51655
Product ID: 51655-087_46ddcd42-e20f-656c-e063-6294a90a7e5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alfuzosin Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA079060
Marketing category: ANDA
Marketing start: 2022-10-04
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (package): 51655-087-52 ndc (product): 51655-087 ndc11 (package): 51655008752

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
f2a530bd-6a86-251d-e053-2995a90adac4	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	Strength	SPL version
51655-087-52	Alfuzosin Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-087	ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20230216_f2a530bd-6a86-251d-e053-2995a90adac4.zip

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	f2a530bd-6a86-251d-e053-2995a90adac4	2
861132	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet	SCD	f2a530bd-6a86-251d-e053-2995a90adac4	2
861132	alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet	SY	f2a530bd-6a86-251d-e053-2995a90adac4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-087-52	51655008752	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-087-52)	2022-10-04	No	No	Current