Uroxatral

Product NDC: 59212-200
11-digit product format: 592120200
Labeler code: 59212
Product ID: 59212-200_ffbc758d-7556-4269-8947-baa7ddb88541
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alfuzosin HCl
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Advanz Pharma (US) Corp.
Application: NDA021287
Marketing category: NDA
Marketing start: 2013-06-03
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
N021287-001	UROXATRAL	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021287-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021287-001	UROXATRAL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-06-12	`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	N021287-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021287-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021287-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021287-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021287-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021287-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021287-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021287-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021287-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021287-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021287-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021287-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021287-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021287-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021287-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021287-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021287-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021287-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021287-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021287-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021287-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021287-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021287-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021287-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021287-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021287-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021287-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021287-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021287-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021287-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021287-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021287-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021287-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021287-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021287-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021287-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021287-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021287-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021287-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021287-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Uroxatral
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861132	Internal RxNorm lookup
861134	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
9fc7f119-f36b-44cf-945d-940160f3afe3	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
59212-200-10	Uroxatral	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		9
59212-200-30	Uroxatral	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59212-200-10	EA - Each	59212-200	849e6e99-7b1b-4f99-9c34-9cfd9f8025e9	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
alfuzosin hydrochloride	ACTIVE INGREDIENT	75046A1XTN	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
alfuzosin	ACTIVE MOIETY	90347YTW5F	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
ethylcellulose (100 mpa.s)	INACTIVE INGREDIENT	47MLB0F1MV	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
hydrogenated castor oil	INACTIVE INGREDIENT	ZF94AP8MEY	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
povidones	INACTIVE INGREDIENT	FZ989GH94E	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [CONCORDIA PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59212-200	UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [ADVANZ PHARMA (US) CORP.]	9	Current NDC, Legacy NDC, 2 package rows	20250103_9fc7f119-f36b-44cf-945d-940160f3afe3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Uroxatral	ALFUZOSIN HCL	Advanz Pharma (US) Corp.	9fc7f119-f36b-44cf-945d-940160f3afe3	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021287 application number: NDA021287 ndc (product): 59212-200

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	9fc7f119-f36b-44cf-945d-940160f3afe3	9
861134	Uroxatral 10 MG 24HR Extended Release Oral Tablet	PSN	9fc7f119-f36b-44cf-945d-940160f3afe3	9
861134	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet [UroXatral]	SBD	9fc7f119-f36b-44cf-945d-940160f3afe3	9
861132	24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet	SCD	9fc7f119-f36b-44cf-945d-940160f3afe3	9
861134	24 HR UroXatral 10 MG Extended Release Oral Tablet	SY	9fc7f119-f36b-44cf-945d-940160f3afe3	9
861132	alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet	SY	9fc7f119-f36b-44cf-945d-940160f3afe3	9
861134	Uroxatral 10 MG 24 HR Extended Release Oral Tablet	SY	9fc7f119-f36b-44cf-945d-940160f3afe3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59212-200-10	59212020010	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)	2013-06-03	0000-00-00	No	No	Current
59212-200-30	59212020030	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)	2019-01-18	0000-00-00	No	No	Current