Home NDC 43547-898 Bumetanide
Product NDC 43547-898
11-digit product format 435470898
Labeler code 43547
Product ID 43547-898_4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare LLC
Application ANDA212931
Marketing category ANDA
Marketing start 2025-03-01
Substance BUMETANIDE
Active strength 2 mg/1
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212931-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 A212931-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 A212931-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18
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.
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 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212931-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-09-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212931-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-09-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212931-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-09-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Bumetanide
Listing expiration 2026-12-31 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 43547-898-10 Bumetanide 100 in 1 BOTTLE TABLET 100 1 43547-898-50 Bumetanide 500 in 1 BOTTLE TABLET 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-898 BUMETANIDE TABLET [SOLCO HEALTHCARE LLC] 1 Current NDC, 2 package rows 20250302_4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bumetanide BUMETANIDE Proficient Rx LP 51d5f639-5d25-4ada-8bbe-ada2386173bf 2026-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212931 application number: ANDA212931 Bumetanide BUMETANIDE A-S Medication Solutions b338ae20-fc07-4ec5-9e68-be636f75ce1a 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212931 application number: ANDA212931 Bumetanide BUMETANIDE Exelan Pharmaceuticals, Inc. 06745425-e7e7-4413-b9ff-22b121f0ea9a 2026-01-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212931 application number: ANDA212931 Bumetanide BUMETANIDE Solco Healthcare LLC 4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6 2025-03-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212931 application number: ANDA212931 ndc (product): 43547-898
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43547-898-10 43547089810 100 TABLET in 1 BOTTLE (43547-898-10) 100 tablet 2025-03-01 No No Current 43547-898-50 43547089850 500 TABLET in 1 BOTTLE (43547-898-50) 500 tablet 2025-03-01 No No Current