amiloride hydrochloride

Product NDC
57721-671
11-digit product format
577210671
Labeler code
57721
Product ID
57721-671_c7011dc8-3456-83c7-e053-2995a90ac7d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amiloride hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
WINDLAS BIOTECH LIMITED
Application
ANDA204180
Marketing category
ANDA
Marketing start
2021-12-01
Marketing end
0000-00-00
Substance
AMILORIDE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57721-671IInactivated by FDA2026-08-03
excluded packagepackage57721-67157721-671-01IInactivated by FDA2026-08-03
excluded packagepackage57721-67157721-671-05IInactivated by FDA2026-08-03
excluded packagepackage57721-67157721-671-06IInactivated by FDA2026-08-03
excluded packagepackage57721-67157721-671-10IInactivated by FDA2026-08-03
excluded packagepackage57721-67157721-671-16IInactivated by FDA2026-08-03
excluded packagepackage57721-67157721-671-30IInactivated 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 2 · 105 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 packagepackage57721-671-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57721-671-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57721-671-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57721-671-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57721-671-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57721-671-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57721-671-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57721-671-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57721-671-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57721-671-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57721-671-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57721-671-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57721-671-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57721-671-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57721-671-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57721-671-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57721-671-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57721-671-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57721-671-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57721-671-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57721-671-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57721-671-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57721-671-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57721-671-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57721-671-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57721-671-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57721-671-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57721-671-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57721-671-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57721-671-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57721-671-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57721-671-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57721-671-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57721-671-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57721-671-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57721-671-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57721-671-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57721-671-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57721-671-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57721-671-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57721-671-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57721-671-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57721-671-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57721-671-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57721-671-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57721-671-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57721-671-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57721-671-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57721-671-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57721-671-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57721-671-300efc9e666f02…f202fb6c5f17…

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
A204180-001AMILORIDE HYDROCHLORIDEAMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07

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 UTC2026-02A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-073f01610625f2…
2019-09-15 20:21 UTC2019-09A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORALAB2015-08-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204180-001AMILORIDE HYDROCHLORIDE5MGTABLET / ORAL2015-08-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A204180-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204180-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204180-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204180-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204180-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204180-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204180-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204180-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204180-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204180-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204180-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204180-001AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7954898a-d540-405e-aa1d-3553358552e5Product name120150812

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57721-671-01amiloride hydrochloride100 in 1 BOTTLETABLET1005
57721-671-05amiloride hydrochloride500 in 1 BOTTLETABLET5005
57721-671-06amiloride hydrochloride30 in 1 BOTTLETABLET305
57721-671-10amiloride hydrochloride1000 in 1 BOTTLETABLET10005
57721-671-16amiloride hydrochloride90 in 1 BOTTLETABLET905
57721-671-30amiloride hydrochloride10 in 1 BLISTER PACKTABLET105
57721-671-30amiloride hydrochloride10 in 1 CARTONTABLET105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57721-671AMILORIDE HYDROCHLORIDE TABLET [WINDLAS BIOTECH LIMITED]5Legacy NDC, 7 package rows20211201_60e8e566-28c6-99ba-e053-2a91aa0a8dbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977880aMILoride HCl 5 MG Oral TabletPSN60e8e566-28c6-99ba-e053-2a91aa0a8dbe5
977880amiloride hydrochloride 5 MG Oral TabletSCD60e8e566-28c6-99ba-e053-2a91aa0a8dbe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57721-671-0157721067101100 TABLET in 1 BOTTLE (57721-671-01) 100 tablet2021-12-010000-00-00NoNoCurrent
57721-671-0557721067105500 TABLET in 1 BOTTLE (57721-671-05) 500 tablet2021-12-010000-00-00NoNoCurrent
57721-671-065772106710630 TABLET in 1 BOTTLE (57721-671-06) 30 tablet2021-12-010000-00-00NoNoCurrent
57721-671-10577210671101000 TABLET in 1 BOTTLE (57721-671-10) 1000 tablet2021-12-010000-00-00NoNoCurrent
57721-671-165772106711690 TABLET in 1 BOTTLE (57721-671-16) 90 tablet2021-12-010000-00-00NoNoCurrent
57721-671-305772106713010 BLISTER PACK in 1 CARTON (57721-671-30) > 10 TABLET in 1 BLISTER PACK10 blister pack2021-12-010000-00-00NoNoCurrent