Home NDC 50090-7736 Bumetanide
Product NDC 50090-7736
11-digit product format 500907736
Labeler code 50090
Product ID 50090-7736_1f7a9bc7-10d5-47eb-90b4-a68968996d04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA213942
Marketing category ANDA
Marketing start 2025-01-16
Substance BUMETANIDE
Active strength .5 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 A213942-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 A213942-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 A213942-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27
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 A213942-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213942-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213942-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213942-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213942-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213942-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213942-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213942-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213942-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213942-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213942-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213942-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213942-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213942-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213942-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213942-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213942-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213942-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213942-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2024-12-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213942-002 BUMETANIDE 1MG TABLET / ORAL AB 2024-12-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213942-003 BUMETANIDE 2MG TABLET / ORAL AB 2024-12-27 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 .5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197417 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 50090-7736-0 Bumetanide 90 in 1 BOTTLE TABLET 90 1
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bumetanide BUMETANIDE NCS HealthCare of KY, LLC dba Vangard Labs fa4e5faf-c91a-457b-bd2b-14a9add51ac8 2026-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213942 application number: ANDA213942 Bumetanide BUMETANIDE Advagen Pharma Limited 94078edd-b9c0-449e-baaf-a9afceccb407 2026-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213942 application number: ANDA213942 Bumetanide BUMETANIDE A-S Medication Solutions 14e92f79-2c7b-4ab9-844f-e7bd1964f8b2 2025-11-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213942 application number: ANDA213942 ndc (product): 50090-7736 Bumetanide BUMETANIDE REMEDYREPACK INC. c5d87c7c-3d03-4a9a-8f07-382371c55169 2025-09-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213942 application number: ANDA213942 Bumetanide BUMETANIDE REMEDYREPACK INC. de008936-e8a3-4e65-bb6a-d925b68a5f50 2025-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213942 application number: ANDA213942
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7736-0 50090773600 90 TABLET in 1 BOTTLE (50090-7736-0) 90 tablet 2025-10-28 No No Current