Home NDC 50090-7965 Bumetanide
Product NDC 50090-7965
11-digit product format 500907965
Labeler code 50090
Product ID 50090-7965_13df9823-1b56-4de2-ad10-c99508180f39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA219291
Marketing category ANDA
Marketing start 2025-04-03
Substance BUMETANIDE
Active strength 1 mg/1
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A219291-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2025-04-03 A219291-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2025-04-03 A219291-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2025-04-03
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 2026-08-18 06:07:40 2026-07 A219291-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2025-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219291-002 BUMETANIDE 1MG TABLET / ORAL AB 2025-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219291-003 BUMETANIDE 2MG TABLET / ORAL AB 2025-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219291-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2025-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219291-002 BUMETANIDE 1MG TABLET / ORAL AB 2025-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219291-003 BUMETANIDE 2MG TABLET / ORAL AB 2025-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219291-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2025-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219291-002 BUMETANIDE 1MG TABLET / ORAL AB 2025-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219291-003 BUMETANIDE 2MG TABLET / ORAL AB 2025-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219291-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2025-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219291-002 BUMETANIDE 1MG TABLET / ORAL AB 2025-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219291-003 BUMETANIDE 2MG TABLET / ORAL AB 2025-04-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219291-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2025-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219291-002 BUMETANIDE 1MG TABLET / ORAL AB 2025-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219291-003 BUMETANIDE 2MG TABLET / ORAL AB 2025-04-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Bumetanide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUMETANIDE 1 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 197418 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 50090-7965-2 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bumetanide BUMETANIDE A-S Medication Solutions a4dd156d-0f17-43d9-bf78-2d358c50681b 2026-05-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219291 application number: ANDA219291 ndc (product): 50090-7965 Bumetanide BUMETANIDE First Nation Group, LLC 79b77945-74a7-4cb5-8aa0-33a7babdf6d9 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219291 application number: ANDA219291 Bumetanide BUMETANIDE A-S Medication Solutions e3d38c1d-9b35-478e-bc2f-3e82b09a1538 2026-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219291 application number: ANDA219291 Bumetanide BUMETANIDE Lifestar Pharma LLC 51a344b6-acf9-4ac4-b743-1e63e3df7958 2025-04-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219291 application number: ANDA219291
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7965-2 50090796502 90 TABLET in 1 BOTTLE (50090-7965-2) 90 tablet 2026-05-13 No No Current