Home NDC 70860-406 Bumetanide
Product NDC 70860-406
11-digit product format 708600406
Labeler code 70860
Product ID 70860-406_6c2e0628-10ab-4074-93c7-c895b20c16d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bumetanide
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA074441
Marketing category ANDA
Marketing start 2022-02-08
Marketing end 0000-00-00
Substance BUMETANIDE
Active strength 0 mg/mL
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A074441-001 BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074441-001 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 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION 1995-01-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074441-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 1995-01-27 cb3db0bc1861…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70860-406 BUMETANIDE INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.] 4 Legacy NDC 20250130_9ec70fd0-080f-48e4-a133-9d581b88c3d8.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bumetanide BUMETANIDE Sagent Pharmaceuticals c38a404d-a919-4a2c-9fbb-d0655dee9516 2024-04-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074441 application number: ANDA074441
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70860-406-10 70860040610 10 VIAL, MULTI-DOSE in 1 CARTON (70860-406-10) > 10 mL in 1 VIAL, MULTI-DOSE 2022-02-08 0000-00-00 No No Current