Home NDC 0832-0542 Bumetanide
Product NDC 0832-0542
11-digit product format 008320542
Labeler code 0832
Product ID 0832-0542_d53166d9-64ca-4b76-81a7-b70a60c53b12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUMETANIDE
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA209916
Marketing category ANDA
Marketing start 2018-01-30
Marketing end 2026-09-30
Substance BUMETANIDE
Active strength 2 mg/1
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag No
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209916-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 A209916-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 A209916-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23
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 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209916-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209916-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209916-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-01-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bumetanide Active Ingredients# Ingredient, Strength table Ingredient Strength BUMETANIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0Y2S3XUQ5H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197417 Internal RxNorm lookup 197418 Internal RxNorm lookup 197419 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 0832-0542-10 Bumetanide 1000 in 1 BOTTLE TABLET 1000 7 0832-0542-11 Bumetanide 100 in 1 BOTTLE TABLET 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-0542 BUMETANIDE TABLET [UPSHER-SMITH LABORATORIES, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240301_ff5dc8c6-b2f2-41d3-8e56-a953aa721b59.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 · 2 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 0832-0542-10 00832054210 1000 TABLET in 1 BOTTLE (0832-0542-10) 1000 tablet 2018-01-30 2026-09-30 No No Current 0832-0542-11 00832054211 100 TABLET in 1 BOTTLE (0832-0542-11) 100 tablet 2018-01-30 2026-09-30 No No Current