Home NDC 0555-0483 Amiloride Hydrochloride and Hydrochlorothiazide
Product NDC 0555-0483
11-digit product format 005550483
Labeler code 0555
Product ID 0555-0483_3c6d3a11-6d0b-4109-89cd-658827847fea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiloride Hydrochloride and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA071111
Marketing category ANDA
Marketing start 1989-12-01
Substance AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength 5; 50 mg/1; mg/1
Pharmacologic classes Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0555-0483 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 0555-0483 0555-0483-99 UNFINISHED Active or certified unfinished drug listing 2026-10-05
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 · 28 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 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0555-0483-99 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0555-0483-99 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0555-0483-99 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0555-0483-99 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0555-0483-99 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0555-0483-99 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0555-0483-99 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0555-0483-99 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0555-0483-99 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0555-0483-99 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0555-0483-99 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0555-0483-99 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0555-0483-99 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0555-0483-99 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071111-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071111-001 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET / ORAL AB 1988-05-10 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amiloride Hydrochloride and Hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMILORIDE HYDROCHLORIDE 5 mg/1 HYDROCHLOROTHIAZIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FZJ37245UC Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 977883 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 0555-0483-02 Amiloride Hydrochloride and Hydrochlorothiazide 100 in 1 BOTTLE TABLET 100 12 0555-0483-05 Amiloride Hydrochloride and Hydrochlorothiazide 1000 in 1 BOTTLE TABLET 1000 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-0483 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20230922_8b2c581a-f955-4a8e-bf85-e768e903fd10.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 0555-0483-02 00555048302 100 TABLET in 1 BOTTLE (0555-0483-02) 100 tablet 1989-12-01 0000-00-00 No No Current 0555-0483-05 00555048305 1000 TABLET in 1 BOTTLE (0555-0483-05) 1000 tablet 1989-12-01 0000-00-00 No No Current 0555-0483-99 00555048399 60000 TABLET in 1 PAIL (0555-0483-99) 60000 tablet 24-MAY-23 Current