Alfuzosin hydrochloride

Product NDC: 63629-9155
11-digit product format: 636299155
Labeler code: 63629
Product ID: 63629-9155_f10b905b-346c-493f-ad51-54c0b9e0d3a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alfuzosin hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203192
Marketing category: ANDA
Marketing start: 2016-03-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A203192-001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203192-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A203192-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203192-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203192-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203192-001	AB	1	`3a93d1ddd44b…`

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: 2026-12-31

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
c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda	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
63629-9155-1	Alfuzosin hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	103
63629-9155-2	Alfuzosin hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	60	103
63629-9155-3	Alfuzosin hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90	103
63629-9155-4	Alfuzosin hydrochloride	120 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	120	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-9155	ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 4 package rows	20240524_c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda.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	Northwind Health Company, LLC	ffbd22eb-9df5-e0ad-e053-6294a90a7d4e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203192 application number: ANDA203192
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203192 application number: ANDA203192 ndc (product): 63629-9155
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	644295a9-75cb-4326-a71f-b0f4e0c4cf75	2022-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203192 application number: ANDA203192

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	c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda	103
861132	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet	SCD	c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda	103
861132	alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet	SY	c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-9155-1	63629915501	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-1)	2022-04-29	0000-00-00	No	No	Current
63629-9155-2	63629915502	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-2)	2022-04-29	0000-00-00	No	No	Current
63629-9155-3	63629915503	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-3)	2022-04-29	0000-00-00	No	No	Current
63629-9155-4	63629915504	120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9155-4)	2022-04-29	0000-00-00	No	No	Current