Alfuzosin hydrochloride

Product NDC
63629-7907
11-digit product format
636297907
Labeler code
63629
Product ID
63629-7907_765f4f51-d655-4e24-bf8d-69eb03230e46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203192
Marketing category
ANDA
Marketing start
2016-03-15
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
2023-12-31
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 productproduct63629-7907IInactivated by FDA2026-08-03
excluded packagepackage63629-790763629-7907-1IInactivated 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 packagepackage63629-7907-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7907-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7907-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7907-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7907-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7907-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7907-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7907-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7907-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7907-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7907-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7907-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7907-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7907-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7907-11332a3947898…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
A203192-001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203192-001AB

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 UTC2026-02A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203192-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-01-28cb3db0bc1861…

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 UTC2026-02A203192-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203192-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203192-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203192-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203192-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203192-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203192-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203192-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203192-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203192-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203192-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203192-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203192-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203192-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203192-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203192-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203192-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203192-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203192-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203192-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203192-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203192-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203192-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203192-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203192-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203192-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203192-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203192-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203192-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203192-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203192-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203192-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203192-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203192-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203192-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203192-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203192-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203192-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203192-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203192-001AB1cb3db0bc1861…

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
63629-7907-1Alfuzosin hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7907ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]3Legacy NDC, 1 package rows20220507_0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab.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 HYDROCHLORIDENorthwind Health Company, LLCffbd22eb-9df5-e0ad-e053-6294a90a7d4e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203192
application number: ANDA203192
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepackc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda2024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203192
application number: ANDA203192
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.644295a9-75cb-4326-a71f-b0f4e0c4cf752022-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203192
application number: ANDA203192

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7907-16362979070190 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7907-1) 2019-02-050000-00-00NoNoCurrent