Alfuzosin Hydrochloride

Product NDC
60505-2850
11-digit product format
605052850
Labeler code
60505
Product ID
60505-2850_5632aa3d-c35f-10fe-3ad1-7d1632a1c1c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA079013
Marketing category
ANDA
Marketing start
2023-09-08
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-285060505-2850-0DDiscontinued by firm2026-08-03
excluded packagepackage60505-285060505-2850-1DDiscontinued by firm2026-08-03
excluded packagepackage60505-285060505-2850-3DDiscontinued by firm2026-08-03
excluded packagepackage60505-285060505-2850-5DDiscontinued by firm2026-08-03
excluded packagepackage60505-285060505-2850-7DDiscontinued by firm2026-08-03
excluded packagepackage60505-285060505-2850-8DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0560505-2850-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-2850-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-2850-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-2850-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-2850-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-2850-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2660505-2850-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-2850-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-2850-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-2850-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-2850-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-2850-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3160505-2850-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-2850-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-2850-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-2850-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-2850-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-2850-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2860505-2850-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-2850-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-2850-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-2850-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-2850-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-2850-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2160505-2850-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-2850-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-2850-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-2850-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-2850-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-2850-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1060505-2850-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-2850-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-2850-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-2850-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-2850-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-2850-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3160505-2850-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-2850-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-2850-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-2850-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-2850-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-2850-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2060505-2850-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-2850-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-2850-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-2850-7ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-2850-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-2850-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1060505-2850-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-2850-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-2850-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-2850-70efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-2850-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-2850-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0860505-2850-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-2850-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-2850-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-2850-7ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-2850-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-2850-8ad56d346431e…cc804d4bbf1e…

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
A079013-001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079013-001AB

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 UTC2026-02A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079013-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18cb3db0bc1861…

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 UTC2026-02A079013-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079013-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079013-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079013-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079013-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079013-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079013-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079013-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079013-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079013-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079013-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079013-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079013-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079013-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079013-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079013-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079013-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079013-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079013-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079013-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079013-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079013-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079013-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079013-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079013-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079013-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079013-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079013-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079013-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079013-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079013-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079013-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079013-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079013-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079013-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079013-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079013-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079013-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079013-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079013-001AB1cb3db0bc1861…

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
26fcc267-c8d7-e059-1bcf-830dded43690Available 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
60505-2850-0Alfuzosin Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1017
60505-2850-0Alfuzosin Hydrochloride10 in 1 CARTONTABLET, EXTENDED RELEASE1017
60505-2850-1Alfuzosin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10017
60505-2850-3Alfuzosin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3017
60505-2850-5Alfuzosin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50017
60505-2850-7Alfuzosin Hydrochloride8000 in 1 BOTTLETABLET, EXTENDED RELEASE800017
60505-2850-8Alfuzosin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100017
60505-2850-9Alfuzosin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2850-1EA - Each60505-28502c52c81d-8c40-4802-a882-a7b1d7d83dfb12012-07-24
60505-2850-9EA - Each60505-2850e1ebb5f6-08bf-49f5-8b86-3430ac551bc312023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]9
ALFUZOSIN HYDROCHLORIDEACTIVE INGREDIENT75046A1XTNALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ALFUZOSINACTIVE MOIETY90347YTW5FALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2850ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.]17Current NDC, Legacy NDC, 8 package rows20250412_26fcc267-c8d7-e059-1bcf-830dded43690.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEApotex Corp.26fcc267-c8d7-e059-1bcf-830dded436902025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079013
application number: ANDA079013
ndc (product): 60505-2850

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN26fcc267-c8d7-e059-1bcf-830dded4369017
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD26fcc267-c8d7-e059-1bcf-830dded4369017
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY26fcc267-c8d7-e059-1bcf-830dded4369017
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN0feb7a22-7416-4502-bf6e-6341782d11ab3
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD0feb7a22-7416-4502-bf6e-6341782d11ab3
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY0feb7a22-7416-4502-bf6e-6341782d11ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-2850-06050528500010 in 1 BLISTER PACKHistorical
60505-2850-160505285001100 in 1 BOTTLEHistorical
60505-2850-36050528500330 in 1 BOTTLEHistorical
60505-2850-560505285005500 in 1 BOTTLEHistorical
60505-2850-7605052850078000 in 1 BOTTLEHistorical
60505-2850-8605052850081000 in 1 BOTTLEHistorical
60505-2850-96050528500990 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-2850-9) 2023-09-08NoNoCurrent