Alfuzosin hydrochloride

Product NDC
76282-302
11-digit product format
762820302
Labeler code
76282
Product ID
76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA090284
Marketing category
ANDA
Marketing start
2012-10-02
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090284-001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090284-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-173f01610625f2…
2019-09-15 20:21 UTC2019-09A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090284-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2012-01-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090284-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090284-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090284-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090284-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090284-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090284-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090284-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090284-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090284-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090284-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090284-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090284-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090284-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090284-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090284-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090284-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090284-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090284-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090284-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090284-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090284-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090284-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090284-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090284-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090284-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090284-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090284-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090284-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090284-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090284-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090284-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090284-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090284-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090284-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090284-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090284-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090284-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090284-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090284-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090284-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Alfuzosin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALFUZOSIN HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
75046A1XTNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861132Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f075a897-7bef-4799-b7e2-7e051c461443Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b671e1a-6f8a-5de4-69a7-83132df7952dProduct name320201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-302-01Alfuzosin hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10011
76282-302-05Alfuzosin hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50011
76282-302-10Alfuzosin hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011
76282-302-12Alfuzosin hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE12011
76282-302-90Alfuzosin hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-302-01EA - Each76282-302adb2582e-2546-4a3e-85b0-b639f174b52d12013-02-13
76282-302-05EA - Each76282-30235f5e404-f900-4ccd-82eb-846b095cc80e12014-05-02
76282-302-10EA - Each76282-302aa84c026-2961-435c-af6c-292205a0b24c12024-07-12
76282-302-12EA - Each76282-302a263f4e1-df21-4a73-bf23-5512d8ccb1c412023-04-07
76282-302-90EA - Each76282-302ae9b4a7f-2960-4d72-b371-90aff5e1602312019-04-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-302ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 5 package rows20240605_f075a897-7bef-4799-b7e2-7e051c461443.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEExelan Pharmaceuticals Inc.f075a897-7bef-4799-b7e2-7e051c4614432023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090284
application number: ANDA090284
ndc (product): 76282-302
Alfuzosin Hydrochloride extended releaseALFUZOSIN HYDROCHLORIDECipla USA Inc.3cc028d5-309f-4ce3-a2d7-5804ab57677d2020-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090284
application number: ANDA090284
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC790fe381-4a83-402e-b6c0-2ecde9cac7a72017-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090284
application number: ANDA090284

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNf075a897-7bef-4799-b7e2-7e051c46144311
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDf075a897-7bef-4799-b7e2-7e051c46144311
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYf075a897-7bef-4799-b7e2-7e051c46144311
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN790fe381-4a83-402e-b6c0-2ecde9cac7a72
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD790fe381-4a83-402e-b6c0-2ecde9cac7a72
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY790fe381-4a83-402e-b6c0-2ecde9cac7a72
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN8a677905-e66d-44f7-b564-6c561387ed031
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD8a677905-e66d-44f7-b564-6c561387ed031
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY8a677905-e66d-44f7-b564-6c561387ed031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-302-0176282030201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01) 2012-10-020000-00-00NoNoCurrent
76282-302-0576282030205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05) 2012-10-020000-00-00NoNoCurrent
76282-302-10762820302101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10) 2012-10-02NoNoCurrent
76282-302-1276282030212120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12) 2022-12-010000-00-00NoNoCurrent
76282-302-907628203029090 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90) 2019-01-010000-00-00NoNoCurrent