Alfuzosin Hydrochloride

Product NDC: 69097-844
11-digit product format: 690970844
Labeler code: 69097
Product ID: 69097-844_497e0a60-9b09-4dcc-8cc6-1f13196f2db4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alfuzosin Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA090284
Marketing category: ANDA
Marketing start: 2016-06-30
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

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
A090284-001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2012-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090284-001	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	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090284-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-01-17	`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	A090284-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090284-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090284-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090284-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090284-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090284-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090284-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090284-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090284-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090284-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090284-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090284-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090284-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090284-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090284-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090284-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090284-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090284-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090284-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090284-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090284-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090284-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090284-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090284-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090284-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090284-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090284-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090284-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090284-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090284-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090284-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090284-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090284-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090284-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090284-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090284-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090284-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090284-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090284-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090284-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Alfuzosin Hydrochloride
Brand name suffix: extended release
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
3cc028d5-309f-4ce3-a2d7-5804ab57677d	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
69097-844-02	Alfuzosin Hydrochlorideextended release	30 in 1 BOTTLE	TABLET	30	4
69097-844-05	Alfuzosin Hydrochlorideextended release	90 in 1 BOTTLE	TABLET	90	4
69097-844-07	Alfuzosin Hydrochlorideextended release	100 in 1 BOTTLE	TABLET	100	4
69097-844-12	Alfuzosin Hydrochlorideextended release	500 in 1 BOTTLE	TABLET	500	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-844-07	EA - Each	69097-844	e77c0292-3c7e-4745-9842-0ec4f2ed029d	1	2016-07-19
69097-844-12	EA - Each	69097-844	abb94301-dbff-4c0d-80c6-792120c75ac5	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-844	ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE (ALFUZOSIN HYDROCHLORIDE) TABLET [CIPLA USA INC.]	4	Current NDC, Legacy NDC, 4 package rows	20201008_3cc028d5-309f-4ce3-a2d7-5804ab57677d.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	Exelan Pharmaceuticals Inc.	f075a897-7bef-4799-b7e2-7e051c461443	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090284 application number: ANDA090284
Alfuzosin Hydrochloride extended release	ALFUZOSIN HYDROCHLORIDE	Cipla USA Inc.	3cc028d5-309f-4ce3-a2d7-5804ab57677d	2020-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090284 application number: ANDA090284 ndc (product): 69097-844
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	790fe381-4a83-402e-b6c0-2ecde9cac7a7	2017-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090284 application number: ANDA090284

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	3cc028d5-309f-4ce3-a2d7-5804ab57677d	4
861132	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet	SCD	3cc028d5-309f-4ce3-a2d7-5804ab57677d	4
861132	alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet	SY	3cc028d5-309f-4ce3-a2d7-5804ab57677d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-844-02	69097084402	30 TABLET in 1 BOTTLE (69097-844-02)	30 tablet	2016-06-30	0000-00-00	No	No	Current
69097-844-05	69097084405	90 TABLET in 1 BOTTLE (69097-844-05)	90 tablet	2016-06-30	0000-00-00	No	No	Current
69097-844-07	69097084407	100 TABLET in 1 BOTTLE (69097-844-07)	100 tablet	2016-06-30	0000-00-00	No	No	Current
69097-844-12	69097084412	500 TABLET in 1 BOTTLE (69097-844-12)	500 tablet	2016-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alfuzosin Hydrochloride extended release	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL	2
Alfuzosin Hydrochloride extended release	Cipla USA Inc. \| InvaGen Pharmaceutical Inc	2020-10-01	HUMAN PRESCRIPTION DRUG LABEL	4