Home NDC 51672-4225 Bumetanide
Product NDC 51672-4225
11-digit product format 516724225
Labeler code 51672
Product ID 51672-4225_4db68936-9d9c-1821-e063-6394a90a7f1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA213458
Marketing category ANDA
Marketing start 2023-07-24
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 2027-12-31
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 A213458-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 A213458-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 A213458-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24
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 2 · 60 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 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213458-002 BUMETANIDE 1MG TABLET / ORAL AB 2023-07-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213458-003 BUMETANIDE 2MG TABLET / ORAL AB 2023-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213458-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2023-07-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bumetanide
Listing expiration 2027-12-31 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 51672-4225-1 Bumetanide 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4225 BUMETANIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, 1 package rows 20240522_5c753aae-77b7-4add-8453-385a8f62d7db.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51672-4225-1 51672422501 100 TABLET in 1 BOTTLE (51672-4225-1) 100 tablet 2023-07-24 No No Current