Home NDC 60429-275 Amiloride Hydrochloride
Product NDC 60429-275
11-digit product format 604290275
Labeler code 60429
Product ID 60429-275_d9e6f5a7-8ad8-4945-e053-2a95a90abe79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiloride Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA070346
Marketing category ANDA
Marketing start 1986-01-22
Marketing end 0000-00-00
Substance AMILORIDE HYDROCHLORIDE ANHYDROUS
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60429-275-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60429-275-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 60429-275-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 60429-275-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 60429-275-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 60429-275-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 60429-275-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 60429-275-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 60429-275-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 60429-275-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 60429-275-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 60429-275-01 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070346-001 AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070346-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMILORIDE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 7M458Q65S3 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 AMILORIDE ACTIVE MOIETY 7DZO8EB0Z3 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-275-01 60429027501 100 TABLET in 1 BOTTLE (60429-275-01) 100 tablet 2015-08-31 0000-00-00 No No Current 60429-275-90 60429027590 90 TABLET in 1 BOTTLE (60429-275-90) 90 tablet 2015-08-31 0000-00-00 No No Current