Home NDC 68083-497 Bumetanide
Product NDC 68083-497
11-digit product format 680830497
Labeler code 68083
Product ID 68083-497_d9e3877d-de1a-4047-9866-413958c4cca0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA216434
Marketing category ANDA
Marketing start 2022-05-26
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 A216434-001 BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216434-001 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.
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 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216434-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-05-26 a50c72e98297…
Observed Orange Book normalized TE history# 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 68083-497-01 Bumetanide 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 4 68083-497-10 Bumetanide 10 in 1 CARTON INJECTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-497 BUMETANIDE INJECTION [GLAND PHARMA LIMITED] 4 Current NDC, Legacy NDC, 2 package rows 20220603_4d1ed6b2-c410-4f52-9b8a-aa256c37089e.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bumetanide BUMETANIDE GLENMARK PHARMACEUTICALS INC., USA 680563fe-5d3a-49bc-86a5-740bda2acebe 2023-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216434 application number: ANDA216434 Bumetanide BUMETANIDE Fresenius Kabi USA, LLC a007f3aa-3977-4be3-a9a2-db3d458bca58 2022-09-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216434 application number: ANDA216434 Bumetanide BUMETANIDE Gland Pharma Limited 4d1ed6b2-c410-4f52-9b8a-aa256c37089e 2022-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216434 application number: ANDA216434 ndc (product): 68083-497
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 68083-497-01 68083049701 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical 68083-497-10 68083049710 10 VIAL, MULTI-DOSE in 1 CARTON (68083-497-10) / 10 mL in 1 VIAL, MULTI-DOSE (68083-497-01) 2022-05-26 0000-00-00 No No Current