Home Applications 074225 Application 074225
Type ANDA
Sponsor HERITAGE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG No No 002 BUMETANIDE BUMETANIDE TABLET;ORAL 1MG No No 003 BUMETANIDE BUMETANIDE TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074225-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 A074225-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 A074225-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 123 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 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074225-002 BUMETANIDE 1MG TABLET / ORAL AB 1995-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074225-003 BUMETANIDE 2MG TABLET / ORAL AB 1995-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074225-001 BUMETANIDE 0.5MG TABLET / ORAL AB 1995-04-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-4536 Bumetanide Bumetanide NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-5534 Bumetanide Bumetanide NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8361 bumetanide bumetanide NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-8361 bumetanide bumetanide NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8362 bumetanide bumetanide NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-8362 bumetanide bumetanide NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 14539-700 bumetanide bumetanide Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ANDA Current 14539-700 bumetanide bumetanide Heritage Pharma Labs, Inc ANDA Current 14539-701 bumetanide bumetanide Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ANDA Current 14539-701 bumetanide bumetanide Heritage Pharma Labs, Inc ANDA Current 14539-702 bumetanide bumetanide Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ANDA Current 14539-702 bumetanide bumetanide Heritage Pharma Labs, Inc ANDA Current 33261-983 Bumetanide Bumetanide Aidarex Pharmaceuticals LLC ANDA Current 68071-2019 Bumetanide Bumetanide NuCare Pharmaceuticals, Inc. ANDA Current 68151-0087 Bumetanide Bumetanide Carilion Materials Management ANDA Current