Alfuzosin Hydrochloride

Product NDC
70934-306
11-digit product format
709340306
Labeler code
70934
Product ID
70934-306_d17a80ba-2b1c-abd0-e053-2a95a90a1f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA079057
Marketing category
ANDA
Marketing start
2019-03-21
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-306IInactivated by FDA2026-08-03
excluded packagepackage70934-30670934-306-30IInactivated by FDA2026-08-03

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 1 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-306-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-306-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-306-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-306-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-306-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-306-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-306-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-306-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-306-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-306-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-306-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-306-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70934-306-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70934-306-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70934-306-301332a3947898…d4bfe170f9cd…

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
A079057-001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18

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 UTC2026-02A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079057-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2011-07-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079057-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079057-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079057-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079057-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079057-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079057-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079057-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079057-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079057-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079057-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079057-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079057-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079057-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079057-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079057-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079057-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079057-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079057-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079057-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079057-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079057-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079057-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079057-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079057-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079057-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079057-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079057-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079057-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079057-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079057-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079057-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079057-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079057-001AB1cb3db0bc1861…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-306-30Alfuzosin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-306ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 1 package rows20211229_8b256346-9450-54b5-e053-2995a90ae259.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDENorthwind Health Company, LLCf2f42c98-4118-5f70-e053-2a95a90add022026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079057
application number: ANDA079057
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack3a541efa-9eed-4a27-b602-7999fc6f59aa2024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079057
application number: ANDA079057
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack98fa10c2-7c12-44aa-9112-e2fd6fa71d062024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079057
application number: ANDA079057
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.d2af616e-673a-4fdd-ace8-db2d0f1546042024-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079057
application number: ANDA079057

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN8b256346-9450-54b5-e053-2995a90ae2593
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD8b256346-9450-54b5-e053-2995a90ae2593
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY8b256346-9450-54b5-e053-2995a90ae2593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-306-307093403063030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-306-30) 2019-03-210000-00-00NoNoCurrent