Home NDC 16571-678 Bumetanide
Product NDC 16571-678
11-digit product format 165710678
Labeler code 16571
Product ID 16571-678_ad19edfb-a229-4767-890a-3bf6558ec191
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bumetanide
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc
Application ANDA212019
Marketing category ANDA
Marketing start 2024-06-03
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 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 A212019-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 A212019-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 A212019-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12
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 3 · 111 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 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2019-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212019-002 BUMETANIDE 1MG TABLET / ORAL AB 2019-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212019-003 BUMETANIDE 2MG TABLET / ORAL AB 2019-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL BX 2019-12-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212019-002 BUMETANIDE 1MG TABLET / ORAL BX 2019-12-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212019-003 BUMETANIDE 2MG TABLET / ORAL BX 2019-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212019-001 BUMETANIDE 0.5MG TABLET / ORAL BX 2019-12-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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 · 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 16571-678-01 Bumetanide 100 in 1 BOTTLE TABLET 100 1 16571-678-10 Bumetanide 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-678 BUMETANIDE TABLET [RISING PHARMA HOLDINGS, INC] 1 Current NDC, 2 package rows 20240628_627c9732-eed1-4435-8d79-2e19ab974fd9.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 · 2 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 16571-678-01 16571067801 100 TABLET in 1 BOTTLE (16571-678-01) 100 tablet 2024-06-03 No No Current 16571-678-10 16571067810 1000 TABLET in 1 BOTTLE (16571-678-10) 1000 tablet 2024-06-03 No No Current