Home NDC 42794-005 Amiloride Hydrochloride
Product NDC 42794-005
11-digit product format 427940005
Labeler code 42794
Product ID 42794-005_f1f15fe7-63a8-4708-e053-2a95a90a7dea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiloride Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA079133
Marketing category ANDA
Marketing start 2021-06-14
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 2026-12-31
Current FDA listing Yes 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 A079133-001 AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079133-001 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 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amiloride Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7M458Q65S3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 977880 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42794-005-02 Amiloride Hydrochloride 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-005 AMILORIDE HYDROCHLORIDE TABLET [SIGMAPHARM LABORATORIES, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20230111_de12b6f3-3791-4d78-90e6-c487cf951738.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42794-005-02 42794000502 100 TABLET in 1 BOTTLE (42794-005-02) 100 tablet 2021-06-14 0000-00-00 No No Current