Home NDC 0641-6284 Bumetanide
Product NDC 0641-6284
11-digit product format 006416284
Labeler code 0641
Product ID 0641-6284_cbf46236-4090-445f-ad19-fd9d767deecc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA079196
Marketing category ANDA
Marketing start 2008-04-30
Substance BUMETANIDE
Active strength .25 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079196-001 BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079196-001 AP
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 · 41 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 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079196-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP RS 2008-04-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 .25 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 282486 Internal RxNorm lookup 1727569 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 0641-6284-01 Bumetanide 4 mL in 1 VIAL INJECTION 4 7 0641-6284-10 Bumetanide 10 in 1 CARTON INJECTION 10 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6284 BUMETANIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 7 Current NDC, 2 package rows 20250406_b5a68154-8003-4b80-81e2-e926524fb72c.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 Cardinal Health 107, LLC e7c3c63e-3aea-4b33-b165-7c7449359674 2026-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079196 application number: ANDA079196 Bumetanide BUMETANIDE Hikma Pharmaceuticals USA Inc. b5a68154-8003-4b80-81e2-e926524fb72c 2025-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079196 application number: ANDA079196 ndc (product): 0641-6284 BUMETANIDE BUMETANIDE HF Acquisition Co LLC, DBA HealthFirst 9bd7a71e-0e78-dae7-e053-2995a90ad110 2025-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079196 application number: ANDA079196 Bumetanide BUMETANIDE Hikma Pharmaceuticals USA Inc. 681b5e9d-e2c7-4f29-aaad-e06d4a528c11 2024-04-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079196 application number: ANDA079196 Bumetanide BUMETANIDE Civica, Inc. 308c690f-c2bd-4c32-8728-42ec95425f77 2023-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079196 application number: ANDA079196
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0641-6284-01 00641628401 4 mL in 1 VIAL 4 ml Historical 0641-6284-10 00641628410 10 VIAL in 1 CARTON (0641-6284-10) / 4 mL in 1 VIAL (0641-6284-01) 10 vial 2008-04-30 No No Current