Home NDC 72205-101 Bumetanide
Product NDC 72205-101
11-digit product format 722050101
Labeler code 72205
Product ID 72205-101_387edfd4-be85-41cd-8a6d-14e6a022b5a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Novadoz Pharmaceuticals LLC
Application ANDA215364
Marketing category ANDA
Marketing start 2022-08-06
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 42 .
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 A215364-001 BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215364-001 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 2026-08-18 06:07:40 2026-07 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215364-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2022-08-04 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 72205-101-01 Bumetanide 4 mL in 1 VIAL INJECTION 4 1 72205-101-07 Bumetanide 10 in 1 CARTON INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-101 BUMETANIDE INJECTION [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, Legacy NDC, 2 package rows 20220811_387edfd4-be85-41cd-8a6d-14e6a022b5a9.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bumetanide BUMETANIDE Bryant Ranch Prepack 43ab2dd6-39ba-4a53-aa84-d7975038ef43 2026-05-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215364 application number: ANDA215364 Bumetanide BUMETANIDE Bryant Ranch Prepack 37179b2d-6589-40d8-8121-7561a6791d38 2026-05-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215364 application number: ANDA215364 Bumetanide BUMETANIDE Cardinal Health 107, LLC 68f18d36-ffc2-4481-9286-914cfcf573a0 2026-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215364 application number: ANDA215364 Bumetanide BUMETANIDE Novadoz Pharmaceuticals LLC 387edfd4-be85-41cd-8a6d-14e6a022b5a9 2022-08-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215364 application number: ANDA215364 ndc (product): 72205-101
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 72205-101-01 72205010101 4 mL in 1 VIAL 4 ml Historical 72205-101-07 72205010107 10 VIAL in 1 CARTON (72205-101-07) / 4 mL in 1 VIAL (72205-101-01) 10 vial 2022-08-06 0000-00-00 No No Current