Home NDC 71335-1692 bumetanide
Product NDC 71335-1692
11-digit product format 713351692
Labeler code 71335
Product ID 71335-1692_3bd5380a-6de4-47fa-92b1-9c3d3874a1ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bumetanide
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202900
Marketing category ANDA
Marketing start 2018-05-01
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 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 A202900-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 A202900-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 A202900-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30
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 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202900-002 BUMETANIDE 1MG TABLET / ORAL AB 2018-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202900-003 BUMETANIDE 2MG TABLET / ORAL AB 2018-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202900-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2018-04-30 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
Listing expiration 2026-12-31 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1692 BUMETANIDE TABLET [BRYANT RANCH PREPACK] 4 Current NDC, Legacy NDC, 6 package rows 20240524_a60bfe5f-d0d6-4d15-a3de-32dc68e41af3.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join bumetanide BUMETANIDE A-S Medication Solutions 8b5a38cc-1e76-4821-b286-31bad3bd6913 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202900 application number: ANDA202900 bumetanide BUMETANIDE Bryant Ranch Prepack a60bfe5f-d0d6-4d15-a3de-32dc68e41af3 2024-05-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202900 application number: ANDA202900 ndc (product): 71335-1692 bumetanide BUMETANIDE Zydus Pharmaceuticals (USA) Inc. 525138cd-832a-41d0-84b0-83921b12bd2a 2023-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202900 application number: ANDA202900 bumetanide BUMETANIDE Zydus Lifesciences Limited 82eb62ca-c32b-4ff8-9f71-43219b240480 2023-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202900 application number: ANDA202900 bumetanide BUMETANIDE A-S Medication Solutions cf29e436-b630-4b03-bb9b-9267ae77dc00 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202900 application number: ANDA202900
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 71335-1692-1 71335169201 30 TABLET in 1 BOTTLE (71335-1692-1) 30 tablet 2020-08-17 0000-00-00 No No Current 71335-1692-2 71335169202 90 TABLET in 1 BOTTLE (71335-1692-2) 90 tablet 2021-12-29 0000-00-00 No No Current 71335-1692-3 71335169203 28 TABLET in 1 BOTTLE (71335-1692-3) 28 tablet 2021-12-29 0000-00-00 No No Current 71335-1692-4 71335169204 18 TABLET in 1 BOTTLE (71335-1692-4) 18 tablet 2021-12-29 0000-00-00 No No Current 71335-1692-5 71335169205 60 TABLET in 1 BOTTLE (71335-1692-5) 60 tablet 2021-12-29 0000-00-00 No No Current 71335-1692-6 71335169206 100 TABLET in 1 BOTTLE (71335-1692-6) 100 tablet 2021-12-29 No No Current