Home NDC 14539-702-10 bumetanide
Product NDC 14539-702
Requested package NDC 14539-702-10
11-digit product format 145390702
Labeler code 14539
Product ID 14539-702_138f8bdd-34a5-49c6-832f-0d343aa95c7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bumetanide
Dosage form TABLET
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA074225
Marketing category ANDA
Marketing start 2019-06-01
Marketing end 0000-00-00
Substance BUMETANIDE
Active strength 2 mg/1
Pharmacologic classes Loop Diuretic [EPC],Increased Diuresis at Loop of Henle [PE]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14539-702-10 14539070210 1000 TABLET in 1 BOTTLE (14539-702-10) 1000 tablet 2019-06-01 0000-00-00 No No Current